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Low enrollment was exacerbated by a covid policy related study suspension so the research was stopped.
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Massachusetts Institute of Technology | OTHER |
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The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the risk of endoscopic recurrence of Crohn's disease (CD) in patients after intestinal resection. The specific outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical symptoms, 3) safety and tolerability, and 4) microbial diversity. The research team hypothesizes that FMT will prevent establishment of "pro-inflammatory" microbiome after surgery, leading to a reduced probability of recurrence of macroscopic inflammation. It is also hypothesized that FMT will be safe and well-tolerated in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota Transplant (FMT) | Experimental | Fecal Microbiota Transplant (FMT) via colonoscopy |
|
| Control | No Intervention | No Fecal Microbiota Transplant (FMT) via colonoscopy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplant (FMT) | Biological | Fecal Microbiota Transplant (FMT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Endoscopic Recurrence | Percentage of patients in each arm of the trial who develop endoscopic recurrence within 6 months of ileo-cecal resection. "Endoscopic recurrence" will be defined as a Rutgeert's score of greater than i2 | within 6 months of ileo-cecal resection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Microbial Diversity: Shannon Diversity Index | The Shannon Diversity Index is a measure of entropy and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p_i log(p_i). Lower values indicate more diversity while higher values indicate less diversity. |
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Inclusion Criteria (Patients):
Exclusion Criteria (Patients):
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| Name | Affiliation | Role |
|---|---|---|
| Alan C Moss, MD PhD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States | ||
| Beth Israel Deaconess Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fecal Microbiota Transplant (FMT) | Fecal Microbiota Transplant (FMT) via colonoscopy Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT) |
| FG001 | Control | No Fecal Microbiota Transplant (FMT) via colonoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fecal Microbiota Transplant (FMT) | Fecal Microbiota Transplant (FMT) via colonoscopy Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT) |
| BG001 | Control | No Fecal Microbiota Transplant (FMT) via colonoscopy |
| 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 | Post-operative Endoscopic Recurrence | Percentage of patients in each arm of the trial who develop endoscopic recurrence within 6 months of ileo-cecal resection. "Endoscopic recurrence" will be defined as a Rutgeert's score of greater than i2 | Posted | Number | percentage of participants | within 6 months of ileo-cecal resection |
|
26 weeks
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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 | Fecal Microbiota Transplant (FMT) | Fecal Microbiota Transplant (FMT) via colonoscopy Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Gastrointestinal disorders | Systematic Assessment | Ed visit for diarrhea |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptoms | Gastrointestinal disorders | Systematic Assessment | Diarrhea |
Low enrollment was exacerbated by a covid policy related study suspension so the research was stopped.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Moss, MD, PhD | Boston Medical Center and BU School of Medicine | 617-638-6116 | alan.moss@bmc.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 | Nov 10, 2017 | Dec 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| baseline, 4, 12, and 26 weeks |
| Number of Participants in Clinical Remission at 26 Weeks | Clinical remission is defined as having a Harvey Bradshaw Index (HBI) score <5 at week 26. The HBI can range from 0 to 18 and higher scores are associated with more severe disease. | 26 weeks |
| Adverse Events Frequency | Number of participants with adverse events | 4, 12, and 26 weeks |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| Prior resection | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| Montreal B3 classification | Montreal B3 indicates penetrating Crohn's disease. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Microbial Diversity: Shannon Diversity Index | The Shannon Diversity Index is a measure of entropy and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p_i log(p_i). Lower values indicate more diversity while higher values indicate less diversity. | There was insufficient data collected for any of the timeframes to calculate the Shannon Diversity Index. | Posted | baseline, 4, 12, and 26 weeks |
|
|
|
| Secondary | Number of Participants in Clinical Remission at 26 Weeks | Clinical remission is defined as having a Harvey Bradshaw Index (HBI) score <5 at week 26. The HBI can range from 0 to 18 and higher scores are associated with more severe disease. | Posted | Count of Participants | Participants | 26 weeks |
|
|
|
| Secondary | Adverse Events Frequency | Number of participants with adverse events | Posted | Count of Participants | Participants | 4, 12, and 26 weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 11 |
| 15 |
| EG001 | Control | No Fecal Microbiota Transplant (FMT) via colonoscopy | 0 | 9 | 1 | 9 | 6 | 9 |
|
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| D007410 | Intestinal Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 26 weeks |
|