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The objectives of this study are (1) to determine the efficacy of fecal microbiota transplantation (FMT), given as oral capsules, compared with placebo for the treatment of refractory diarrhea-predominant irritable bowel syndrome (IBS-D); (2) determine the impact of FMT on the intestinal microbiome of patients with IBS-D; and (3) assess the safety, feasibility, and tolerability of FMT for patients with IBS-D.
This is a multicenter study including Montefiore Medical Center, Concorde Medical Group PLLC and the Medical Research Center of Connecticut/Yale-New Haven Hospital Langone Medical Center. Patients with IBS-D will be recruited from outpatient gastroenterology clinics at these institutions and referrals from the medical community.
FMT capsules and placebo capsules, provided by OpenBiome, Medford, MA, will be used for this study. Patients will be randomized to undergo FMT using fecal capsules (experimental group) or placebo capsules (control group) via a computer-generated program. All patients will cross-over into the alternate arm of the study at 12 weeks. Therefore, all patients enrolled will receive the experimental drug during the course of the study. Each patient will be enrolled in the study for a total of 6 months.
Intestinal microbiome analyses using DNA sequencing and non-cultivation-based approaches (16S DNA technology) will be performed in all patients in the experimental and control groups to assess stability of the microbiome over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT capsules | Experimental | Intervention: Fecal microbiota transplantation capsules containing extensively screened donor stool, prepared by OpenBiome, Medford, MA. 25 FMT capsules will be take on three consecutive days. |
|
| Placebo capsules | Placebo Comparator | Intervention: Placebo capsules that do not contain donor stool or any active drug, prepared by OpenBiome, Medford, MA. 25 placebo capsules will be taken on three consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation capsules | Drug | Fecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS) | Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). The scale range was 0-500 (min-max). Scores were averaged among time points to yield an overall mean score. Higher scores were indicative of greater disease severity (worse outcome). Subjects were categorized as having mild (75-175), moderate (175-300), or severe (>300) irritable bowel syndrome (IBS) based on symptomology. Only the following time points were analyzed: Baseline vs Week 12 and Week 24. | Baseline, Week 12 (before cross-over), Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Within and Between Group Comparisons of Quality of Life as Determined by the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Score | Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Quality of Life (IBS-QOL), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). Irritable Bowel Syndrome-Quality of Life (IBS-QOL) is administered via a questionnaire of 34 items each with an individual five-point response scale. The responses to these items are summed and averaged for a total score and then transformed to a 100-point scale for ease of interpretation based on a validated method. IBS-QOL is measured on a scale range of 0-100. Higher IBS-QOL scores are indicative of a better IBS-specific quality of life. Only the following time points were analyzed: Baseline vs Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga C Aroniadis, MD | Montefiore Medical Center | Principal Investigator |
| Lawrence J Brandt, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Center of Connecticut | Hamden | Connecticut | 06518 | United States | ||
| Concorde Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31326345 | Derived | Aroniadis OC, Brandt LJ, Oneto C, Feuerstadt P, Sherman A, Wolkoff AW, Kassam Z, Sadovsky RG, Elliott RJ, Budree S, Kim M, Keller MJ. Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):675-685. doi: 10.1016/S2468-1253(19)30198-0. Epub 2019 Jul 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fecal Microbiota Transplantation Capsules First, Then Placebo | Intervention: 25 Fecal Microbiota Transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3). Patients were seen on Day 10, Week 4, Week 8, and Week 12 after FMT administration. Patients were crossed-over into the Placebo arm at 12 weeks. After cross-over, patients were administered 25 Placebo capsules, that did not contain donor stool or active drug, on each of three consecutive days (Day 1, Day 2, Day 3). Patients were seen on Day 10, Week 4, Week 8, and Week 12 after Placebo dosing. The overall duration of the study was 6 months. FMT capsules contained extensively screened donor stool and are prepared by OpenBiome. Placebo capsules contained saline and glycerol. Both FMT and Placebo capsules were prepared by OpenBiome, Medford, MA. |
| FG001 | Placebo Capsules First, Then Fecal Microbiota Transplantation | Intervention: 25 Placebo capsules, that did not contain donor stool or active drug, were administered on each of three consecutive days (Day 1, Day 2, Day 3). Patients were seen on Day 10, Week 4, Week 8, and Week 12 after Placebo administration. Patients were then crossed-over into the FMT arm at 12 weeks. After cross-over, patients were administered 25 Fecal Microbiota Transplantation (FMT) capsules on each of three consecutive days (Day 1, Day 2, Day 3). Patients were seen on Day 10, Week 4, Week 8, and Week 12 after FMT administration. The overall duration of the study was 6 months. FMT capsules contained extensively screened donor stool and are prepared by OpenBiome. Placebo capsules contained saline and glycerol. Both FMT and Placebo capsules were prepared by OpenBiome, Medford, MA. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (12 Weeks) |
|
| |||||||||||||||||||||
| Second Intervention (12 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fecal Microbiota Transplantation Capsules First, Then Placebo | Intervention: 25 Fecal Microbiota Transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3). At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3). FMT capsules contained extensively screened donor stool and are prepared by OpenBiome. Placebo capsules contained saline and glycerol. Both FMT and Placebo capsules were prepared by OpenBiome, Medford, MA. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS) | Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). The scale range was 0-500 (min-max). Scores were averaged among time points to yield an overall mean score. Higher scores were indicative of greater disease severity (worse outcome). Subjects were categorized as having mild (75-175), moderate (175-300), or severe (>300) irritable bowel syndrome (IBS) based on symptomology. Only the following time points were analyzed: Baseline vs Week 12 and Week 24. | Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 (before cross-over), Week 24 |
6 months
Adverse Events (AEs) were solicited during each patient visit. Additionally, patients, were asked to maintain a daily diary of AEs in a specifically dedicated diary developed by the research team to facilitate standardized reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FMT Capsules | 25 Fecal Microbiota Transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3) at initiation of the trial or at the time of cross-over (week 12). FMT capsules contained extensively screened donor stool and were prepared by OpenBiome, Medford, MA. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cholecystectomy | Gastrointestinal disorders | Systematic Assessment | One study-unrelated SAE was reported. This participant underwent cholecystectomy for acute cholecystitis 2 months after ingesting placebo capsules. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Olga C. Aroniadis, PI | Montefiore Medical Center | 718-920-4846 | oaroniad@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2015 | Jun 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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|
| Placebo capsules | Drug | Placebo capsules prepared by OpenBiome, Medford, MA |
|
| Baseline, Week 12 (before cross-over), Week 24 |
| Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) | Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial. Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed. | Baseline, Week 1, Week 4 and Week 12 |
| Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety) | Anxiety at baseline and at the time of cross-over (Week 12) as measured by Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety) The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which was administered via questionnaire. Seven of the items relate to anxiety (HADS-A) and seven relate to depression (HADS-D). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety. Only the following time points were analyzed: Baseline vs Week 12 | Baseline, Week 12 (before cross-over), Week 24 |
| Depression as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression) | Depression at baseline and at the time of cross-over (Week 12) as measured by Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression) The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which was administered via questionnaire. Seven of the items relate to anxiety (HADS-A) and seven relate to depression (HADS-D). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety. Only the following time points were analyzed: Baseline vs Week 12 | Baseline, Week 12 (before cross-over), Week 24 |
| Bowel Consistency as Measured by the Bristol Stool Form Scale (BSFS) | Bowel consistency as measured by the Bristol Stool Form Scale on a daily basis. The Bristol Stool Form Scale was administered via questionnaire. This scale is a diagnostic medical tool designed to classify the form of human feces into seven categories. Assigned categories range from 1-7 based on appearance of the stool. Type 1 and 2 stools indicate constipation. Type 4 are the ideal stools as they are easy to defecate while not containing excess liquid, Type 5 tends towards diarrhea, and Types 6 and 7 indicate diarrhea. Only the following time points were analyzed: Baseline vs Week 12 | Baseline, Week 12 (before cross-over), Week 24 |
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | The total number of participants in each of the arms/groups (FMT and Placebo) who experienced at least one adverse event (AE) as recorded in patient diaries. | All AEs over 24 weeks |
| Satisfaction With Fecal Microbiota Transplantation (FMT) | Weekly assessments of satisfaction with the Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries. | Week 12 following administration of FMT |
| Change in Bowel Habits and Abdominal Pain After Fecal Microbiota Transplantation (FMT) | Degree of improvement in bowel habits and abdominal pain will be recorded in patient diaries. | Week 12 following administration of FMT |
| Number of Doctor or Emergency Department (ED) Visits Post-Fecal Microbiota Transplantation (Post-FMT) for Irritable Bowel Syndrome-D (IBS-D) Related Symptoms | The number of doctor or ED visits post-Fecal Microbiota Transplantation for Irritable Bowel Syndrome-D (IBS-D) related symptoms will be recorded in patient diaries. | Week 12 following administration of FMT |
| Initiation of New Medications Post-FMT for the Treatment of IBS-D Symptoms | Initiation of new medications post-FMT for the treatment of IBS-D symptoms will be recorded in patient diaries. | Week 12 following administration of FMT |
| Patient Attitudes Towards Fecal Microbiota Transplantation (FMT) | Patient attitudes towards Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries. | Week 12 following administration of FMT |
| Tolerability of Fecal Microbiota Transplantation (FMT) | Tolerability of Fecal Microbiota Transplantation (FMT) will be maintained in patient diaries. | Week 12 following administration of FMT |
| Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) | Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial. Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed. The Alpha Diversity Index is a quantitative measure that reflects the diversity of bacterial species in a sample. The greater the index, the more diverse the intestinal microbiota. | Baseline, Week 1, Week 4 and Week 12 |
| Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) | Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial. Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed. The Beta Diversity Index or Jensen-Shannon divergence is a quantitative measure that reflects the diversity of bacterial species between two different regions. The greater the index, the more diverse the intestinal microbiota between the two regions. | Baseline, Week 1, Week 4 and Week 12 |
| Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) | Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial. Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed. Information on abundance of Prevotella was only available at baseline and week 1. | Baseline and Week 1 |
| New York |
| New York |
| 10016 |
| United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| NOT COMPLETED |
|
| BG001 | Placebo Capsules First, Then Fecal Microbiota Transplantation | Intervention: 25 Placebo capsules, that did not contain donor stool or active drug, were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3). FMT capsules contained extensively screened donor stool and are prepared by OpenBiome. Placebo capsules contained saline and glycerol. Both FMT and Placebo capsules were prepared by OpenBiome, Medford, MA. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | 'More than one race' category identified as "Other" in study data | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| IBS-SSS | Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS) is measured on a scale range of 0-500 (min-max) via administration of a questionnaire. Higher scores are indicative of greater disease severity of symptoms based on a validated method. Subjects are categorized as having mild (75-175), moderate (175-300), or severe (>300) irritable bowel syndrome (IBS) based on symptomology. | Mean | Standard Deviation | units on a scale |
|
| IBS-QOL | Irritable Bowel Syndrome-Quality of Life (IBS-QOL) is administered via a questionnaire of 34 items each with an individual five-point response scale. The responses to these items are summed and averaged for a total score and then transformed to a 100-point scale for ease of interpretation based on a validated method. IBS-QOL is measured on a scale range of 0-100. Higher IBS-QOL scores are indicative of a better IBS-specific quality of life. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety) | The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which is administered via questionnaire. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety. HADS-A (Anxiety component) | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale (HADS) HADS-D (Depression) | The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which is administered via questionnaire. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety. HADS-D (Depression component) | Mean | Standard Deviation | units on a scale |
|
| Bristol Stool Form Scale (BSFS) | The Bristol Stool Form Scale is administered via questionnaire. This scale is a diagnostic medical tool designed to classify the form of human feces into seven categories. Assigned categories range from 1-7 based on appearance of the stool. Type 1 and 2 stools indicate constipation. Type 4 are the ideal stools as they are easy to defecate while not containing excess liquid, Type 5 tends towards diarrhea, and Types 6 and 7 indicate diarrhea. | Mean | Standard Deviation | units on a scale |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | FMT Capsules, Followed by Placebo Capsules | Intervention: 25 fecal microbiota transplantation (FMT) capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received placebo capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks. |
| OG001 | Placebo Capsules, Followed by FMT Capsules | Intervention: 25 placebo capsules were administered on each of three consecutive days (Day 1, Day 2, Day 3), then patients were followed for 12 weeks. At 12 weeks, patients crossed over into the alternate arm and received fecal microbiota transplantation capsules on each of three consecutive days (Day 1, Day 2, Day 3). Analyses included change in outcome measure between baseline and 12 weeks. |
|
|
| Secondary | Within and Between Group Comparisons of Quality of Life as Determined by the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Score | Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Quality of Life (IBS-QOL), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). Irritable Bowel Syndrome-Quality of Life (IBS-QOL) is administered via a questionnaire of 34 items each with an individual five-point response scale. The responses to these items are summed and averaged for a total score and then transformed to a 100-point scale for ease of interpretation based on a validated method. IBS-QOL is measured on a scale range of 0-100. Higher IBS-QOL scores are indicative of a better IBS-specific quality of life. Only the following time points were analyzed: Baseline vs Week 12 | Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. As such, data for crossover intervention couldn't be reported. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 (before cross-over), Week 24 |
|
|
|
| Secondary | Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) | Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial. Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed. | Posted | Mean | Standard Deviation | percentage of bacteria | Baseline, Week 1, Week 4 and Week 12 |
|
|
|
| Secondary | Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety) | Anxiety at baseline and at the time of cross-over (Week 12) as measured by Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety) The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which was administered via questionnaire. Seven of the items relate to anxiety (HADS-A) and seven relate to depression (HADS-D). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety. Only the following time points were analyzed: Baseline vs Week 12 | Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. As such, data for crossover intervention couldn't be reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 (before cross-over), Week 24 |
|
|
|
| Secondary | Depression as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression) | Depression at baseline and at the time of cross-over (Week 12) as measured by Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression) The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which was administered via questionnaire. Seven of the items relate to anxiety (HADS-A) and seven relate to depression (HADS-D). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety. Only the following time points were analyzed: Baseline vs Week 12 | Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. As such, data for crossover intervention couldn't be reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 (before cross-over), Week 24 |
|
|
|
| Secondary | Bowel Consistency as Measured by the Bristol Stool Form Scale (BSFS) | Bowel consistency as measured by the Bristol Stool Form Scale on a daily basis. The Bristol Stool Form Scale was administered via questionnaire. This scale is a diagnostic medical tool designed to classify the form of human feces into seven categories. Assigned categories range from 1-7 based on appearance of the stool. Type 1 and 2 stools indicate constipation. Type 4 are the ideal stools as they are easy to defecate while not containing excess liquid, Type 5 tends towards diarrhea, and Types 6 and 7 indicate diarrhea. Only the following time points were analyzed: Baseline vs Week 12 | Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. As such, data for crossover intervention couldn't be reported. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 (before cross-over), Week 24 |
|
|
|
| Secondary | Number of Participants With Adverse Events as a Measure of Safety and Tolerability | The total number of participants in each of the arms/groups (FMT and Placebo) who experienced at least one adverse event (AE) as recorded in patient diaries. | Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were pooled together into one group. | Posted | Count of Participants | Participants | All AEs over 24 weeks |
|
|
|
| Secondary | Satisfaction With Fecal Microbiota Transplantation (FMT) | Weekly assessments of satisfaction with the Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries. | Data was not collected and, therefore, the outcome cannot be reported. | Posted | Week 12 following administration of FMT |
|
|
| Secondary | Change in Bowel Habits and Abdominal Pain After Fecal Microbiota Transplantation (FMT) | Degree of improvement in bowel habits and abdominal pain will be recorded in patient diaries. | Data was not collected and, therefore, the outcome cannot be reported. | Posted | Week 12 following administration of FMT |
|
|
| Secondary | Number of Doctor or Emergency Department (ED) Visits Post-Fecal Microbiota Transplantation (Post-FMT) for Irritable Bowel Syndrome-D (IBS-D) Related Symptoms | The number of doctor or ED visits post-Fecal Microbiota Transplantation for Irritable Bowel Syndrome-D (IBS-D) related symptoms will be recorded in patient diaries. | Data was not collected and, therefore, the outcome cannot be reported. | Posted | Week 12 following administration of FMT |
|
|
| Secondary | Initiation of New Medications Post-FMT for the Treatment of IBS-D Symptoms | Initiation of new medications post-FMT for the treatment of IBS-D symptoms will be recorded in patient diaries. | Data was not collected and, therefore, the outcome cannot be reported. | Posted | Week 12 following administration of FMT |
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|
| Secondary | Patient Attitudes Towards Fecal Microbiota Transplantation (FMT) | Patient attitudes towards Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries. | Data was not collected and, therefore, the outcome cannot be reported. | Posted | Week 12 following administration of FMT |
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| Secondary | Tolerability of Fecal Microbiota Transplantation (FMT) | Tolerability of Fecal Microbiota Transplantation (FMT) will be maintained in patient diaries. | Data was not collected and, therefore, the outcome cannot be reported. | Posted | Week 12 following administration of FMT |
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| Secondary | Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) | Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial. Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed. The Alpha Diversity Index is a quantitative measure that reflects the diversity of bacterial species in a sample. The greater the index, the more diverse the intestinal microbiota. | Posted | Mean | Standard Deviation | index | Baseline, Week 1, Week 4 and Week 12 |
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| Secondary | Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) | Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial. Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed. The Beta Diversity Index or Jensen-Shannon divergence is a quantitative measure that reflects the diversity of bacterial species between two different regions. The greater the index, the more diverse the intestinal microbiota between the two regions. | Posted | Mean | Standard Deviation | index | Baseline, Week 1, Week 4 and Week 12 |
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| Secondary | Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) | Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial. Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed. | Posted | Mean | Standard Deviation | percentage of bacteria | Baseline, Week 1, Week 4 and Week 12 |
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| Secondary | Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) | Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial. Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed. Information on abundance of Prevotella was only available at baseline and week 1. | Posted | Mean | Standard Deviation | percentage of bacteria | Baseline and Week 1 |
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| 0 |
| 48 |
| 0 |
| 48 |
| 23 |
| 48 |
| EG001 | Placebo Capsules | 25 placebo capsules, that did not contain donor stool or any active drug, were administered on each of three consecutive days (Day 1, Day 2, Day 3) at initiation of the trial or at the time of cross-over (week 12). Placebo capsules contained saline and glycerol. ann were prepared by OpenBiome, Medford, MA. | 0 | 48 | 1 | 48 | 24 | 48 |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Worsening of Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Regurgitation/Emesis | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | Gastrointestinal disorders | Systematic Assessment |
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| Gas | Gastrointestinal disorders | Systematic Assessment |
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| Belching | Gastrointestinal disorders | Systematic Assessment |
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| Loss of Appetite | Gastrointestinal disorders | Systematic Assessment |
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Not provided
Not provided
| D004066 | Digestive System Diseases |
| Week 24 |
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| Bacteroidetes - Week 4 |
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| Bacteroidetes - Week 12 |
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| Week 24 |
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| Week 24 |
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| Week 24 |
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| Alpha Diversity - Week 4 |
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| Alpha Diversity - Week 12 |
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| Jensen Shannon Diversity - Week 4 |
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| Jensen Shannon Diversity - Week 12 |
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| Firmicutes - Week 4 |
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| Firmicutes - Week 12 |
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