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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK099919 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Brigham and Women's Hospital | OTHER |
| George Washington University | OTHER |
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The Microbiome trial is a non-randomized, open-label, sequential, multi-center study of p-inulin for patients with hemodialysis-dependent end-stage renal disease.
This primary objective of this exploratory study is to characterize the safety and tolerability of p-inulin (Prebiotin®, provided by JGI Medical) in altering the composition and function of the human gut microbiome, thereby reducing the generation of gut-derived uremic toxins, improving gut barrier function and attenuating systemic inflammation in patients treated with maintenance hemodialysis. The study also aims to assess the feasibility of conducting a full-scale trial of p-inulin. The primary efficacy parameters of the trial will be intra- and inter-participant variability in gut metabolites and bacterial composition. Secondary parameters of interest include tolerability and safety of p-inulin, willingness of hemodialysis patients to enroll in a study requiring repeated collection of stool samples, and participant adherence to agent treatment and specimen collection schedules.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | This is a sequential study in which participants are observed (no intervention) for 8 weeks (pre-treatment), then participants self-administer p-inulin 8g orally twice daily for 12 weeks (treatment phase), and then observed for a final 8 weeks during which no treatment was administered (post-treatment). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| p-inulin | Dietary Supplement | 12 week self-administered treatment phase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Within Participant Variability in Microbiome Composition by Treatment Phase | The weighted UniFrac distance was used to compute the distances for each sample. Weighted UniFrac distance uses species abundance information and weights the branch length with abundance difference. Weighted UniFrac distance is most sensitive to detect change in abundant lineages since it uses absolute abundance difference in its definition. | 28 weeks |
| Within Participant Variability in Stool Metabolome by Treatment Phase | The Euclidean distance was used to compute the distances for each sample. The Euclidean distance is defined as the distance between two points. Differences between samples were determined on the basis of distances from the initial measurements to account for participant-level differences in initial abundance of microorganisms. | 28 weeks |
| Within Participant Variability in Plasma Metabolome by Treatment Phase | The Euclidean distance was used to compute the distances for each sample. The Euclidean distance is defined as the distance between two points. Differences between samples were determined on the basis of distances from the initial measurements to account for participant-level differences in initial abundance of microorganisms. | 28 weeks (8 weeks pre-treatment, 12 weeks of treatment, 8 weeks post-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score of Gastrointestinal Symptom Rating Scale (GSRS) (Safety Outcome) | Gastrointestinal symptoms as measure by the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS total score is the sum of 15 0-3 items where 0 indicates absence and 3 an extreme degree of the symptom. A higher score indicates worse outcome. The minimum score is 0, the maximum score is 45. | GSRS was assessed at Weeks 0, 4, 8, 12, 16, 20, 24 and 28. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Dember, MD | University of Pennsylvania | Principal Investigator |
| J Richard Landis, PhD | Perelman School of Medicine at the University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The George Washington University | Washington D.C. | District of Columbia | 20037 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35369018 | Derived | Raj DS, Sohn MB, Charytan DM, Himmelfarb J, Ikizler TA, Mehrotra R, Ramezani A, Regunathan-Shenk R, Hsu JY, Landis JR, Li H, Kimmel PL, Kliger AS, Dember LM; Hemodialysis Novel Therapies Consortium. The Microbiome and p-Inulin in Hemodialysis: A Feasibility Study. Kidney360. 2021 Jan 15;2(3):445-455. doi: 10.34067/KID.0006132020. eCollection 2021 Mar 25. |
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The protocol allowed for enrollment of up to 20 individuals with the goal or having 10 participants complete the first 20 weeks of the study with satisfactory completeness of biosample collection.
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| ID | Title | Description |
|---|---|---|
| FG000 | Full Study Cohort | This was a sequential study in which participants moved through 3 phases - 8 weeks during which no treatment was administed, 12 weeks during which p-inulin was self-administered orally, 8g twice daily, and another 8 weeks during which no treatment was administered. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
This trial had a sequential design in which participants moved from pre-treatment phase to the treatment phase and then to the post-treatment phaseThe baseline characteristics for the group of 13 participants is shown under pre-treatment phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | This is a sequential study in which participants are observed (no intervention) for 8 weeks (pre-treatment), then participants self-administer p-inulin 8g orally twice daily for 12 weeks (treatment phase), and then observed for a final 8 weeks during which no treatment was administered (post-treatment). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Participant Variability in Microbiome Composition by Treatment Phase | The weighted UniFrac distance was used to compute the distances for each sample. Weighted UniFrac distance uses species abundance information and weights the branch length with abundance difference. Weighted UniFrac distance is most sensitive to detect change in abundant lineages since it uses absolute abundance difference in its definition. | Two participants withdrew at the beginning of the second phase of the trial. One participant with antibiotic use was not included in the microbiome composition analysis. | Posted | Median | Inter-Quartile Range | weighted unifrac distrance | 28 weeks |
|
28 weeks from Baseline to End of Study
This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase.
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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 | Pre-treatment | This arm is the 8-week observation period before the p-inulin treatment phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Graft thrombosis | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie Kuzla | University of Pennsylvania | 215-573-2935 | nkuzla@pennmedicine.upenn.edu |
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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 | Sep 9, 2015 | Jul 22, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 9, 2015 | Jul 22, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Vanderbilt University |
| OTHER |
| University of Washington | OTHER |
This is a sequential trial that included three sequential phases: 1. Pre-treatment phase: 8 weeks during which no treatment was administered 2. p-Inulin phase: 12 weeks during which p-inulin was administered 8g orally twice daily 3. Post-treatment phase: 8 weeks during which no treatment was administered. Eleven of the 13 participants in the p-inulin phase entered the post-treatment phase. The other two withdrew prior to the post-treatment phase.
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| Number of Participants Who Discontinued Use of P-inulin (Tolerability Outcome) | -Early discontinuation of p-inulin | 12 weeks |
| Number of Participants Who Reduce the Dose of P-inulin (Tolerability Outcome) | -Reduction in p-inulin dose | 12 weeks |
| Number of Participants With Adverse Events (Safety Outcome) | -Adverse events per participant related to treatment as coded using the Medical Dictionary for Regulatory Activities (MedDRA) Coding System | 28 weeks |
| Number of Serious Adverse Events (Safety Outcome) | Serious adverse events categorized by body systems, related to treatment as coded using the Medical Dictionary for Regulatory Activities (MedDRA) Coding System | 28 weeks |
| Rate of Enrollment Refusal (Feasibility Outcome) | Enrollment refusal rate | 1 year |
| Stool Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome) | Percent of expected completed protocol-specified stool sample collections | 28 weeks |
| Blood Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome) | Proportion of completed blood sample collections | 28 weeks |
| Adherence Rate of P-inulin Use (Feasibility Outcome) | Proportion of p-inulin packets used | 12 weeks |
| Rate of Study Withdrawal (Feasibility Outcome) | Number of withdrawals during each phase of the study | 28 weeks |
| Boston |
| Massachusetts |
| 02120 |
| United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Kidney Research Institute, University of Washington | Seattle | Washington | 98104 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Within Participant Variability in Stool Metabolome by Treatment Phase | The Euclidean distance was used to compute the distances for each sample. The Euclidean distance is defined as the distance between two points. Differences between samples were determined on the basis of distances from the initial measurements to account for participant-level differences in initial abundance of microorganisms. | Two participants withdrew at the beginning of the second phase of the trial. One participant with antibiotic use was not included in the microbiome composition analysis. | Posted | Median | Inter-Quartile Range | Euclidean distance | 28 weeks |
|
|
|
| Primary | Within Participant Variability in Plasma Metabolome by Treatment Phase | The Euclidean distance was used to compute the distances for each sample. The Euclidean distance is defined as the distance between two points. Differences between samples were determined on the basis of distances from the initial measurements to account for participant-level differences in initial abundance of microorganisms. | Two participants withdrew at the beginning of the second phase of the trial. One participant with antibiotic use was not included in the microbiome composition analysis. | Posted | Median | Inter-Quartile Range | Euclidean distance | 28 weeks (8 weeks pre-treatment, 12 weeks of treatment, 8 weeks post-treatment) |
|
|
|
| Secondary | Change in Score of Gastrointestinal Symptom Rating Scale (GSRS) (Safety Outcome) | Gastrointestinal symptoms as measure by the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS total score is the sum of 15 0-3 items where 0 indicates absence and 3 an extreme degree of the symptom. A higher score indicates worse outcome. The minimum score is 0, the maximum score is 45. | Two participants withdrew at the beginning of the second phase of the trial. | Posted | Mean | Standard Deviation | score on a scale | GSRS was assessed at Weeks 0, 4, 8, 12, 16, 20, 24 and 28. |
|
|
|
| Secondary | Number of Participants Who Discontinued Use of P-inulin (Tolerability Outcome) | -Early discontinuation of p-inulin | This outcome is only relevant during the p-inulin phase. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Number of Participants Who Reduce the Dose of P-inulin (Tolerability Outcome) | -Reduction in p-inulin dose | Three participants reduced their p-inulin dose. This analysis only applies to the 12 week treatment arm. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Number of Participants With Adverse Events (Safety Outcome) | -Adverse events per participant related to treatment as coded using the Medical Dictionary for Regulatory Activities (MedDRA) Coding System | Posted | Number | participants | 28 weeks |
|
|
|
| Secondary | Number of Serious Adverse Events (Safety Outcome) | Serious adverse events categorized by body systems, related to treatment as coded using the Medical Dictionary for Regulatory Activities (MedDRA) Coding System | This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase. | Posted | Number | Serious Adverse Events | 28 weeks |
|
|
|
| Secondary | Rate of Enrollment Refusal (Feasibility Outcome) | Enrollment refusal rate | Data not collected | Posted | 1 year |
|
|
| Secondary | Stool Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome) | Percent of expected completed protocol-specified stool sample collections | This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment arm. | Posted | Number | percentage of expected | 28 weeks |
|
|
|
| Secondary | Blood Specimen Collection Proportion - Protocol Adherence (Feasibility Outcome) | Proportion of completed blood sample collections | This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase. | Posted | Number | percentage of expected | 28 weeks |
|
|
|
| Secondary | Adherence Rate of P-inulin Use (Feasibility Outcome) | Proportion of p-inulin packets used | This is a sequential trial. The 13 participants from the pre-treatment phase moved to the p-inulin phase. Eleven of the 13 participants entered the post-treatment phase. Two participants withdrew prior to the post-treatment phase. | Posted | Number | percent | 12 weeks |
|
|
|
| Secondary | Rate of Study Withdrawal (Feasibility Outcome) | Number of withdrawals during each phase of the study | Posted | Count of Participants | Participants | 28 weeks |
|
|
|
| 0 |
| 13 |
| 2 |
| 13 |
| 1 |
| 13 |
| EG001 | P-inulin | This arm is the 12 week p-inulin treatment phase (8 grams twice daily, oral). p-inulin: 12 week self-administered treatment phase | 0 | 11 | 0 | 11 | 2 | 11 |
| EG002 | Post-treatment | This arm is the 8-week observation period after the p-inulin treatment phase. | 0 | 11 | 1 | 11 | 0 | 11 |
| Graft dysfunction | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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