Back to resultsFecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fecal microbiota transplantation capsules
Placebo capsules
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring fecal microbiota transplantation, diarrhea-predominant
Eligibility Criteria
Inclusion Criteria:
- age 19-65 years
- established diagnosis of IBS-D as determined by Rome III Criteria
- moderate-severe disease activity (as determined by an IBS-Symptom Severity Score ≥175)
- persistent symptoms despite conventional therapy
- normal colonoscopy with biopsies in the past for work-up of IBS symptoms
- negative work-up for celiac disease either by duodenal biopsies or negative serologies
Exclusion Criteria:
- pregnancy
- nursing
- cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent
- severely immunocompromised or immunosuppressed patients (e.g., organ transplant recipients, severe neutropenia with an absolute neutrophil count of <500cells/mL, current treatment or treatment within 3 months with anti-neoplastic agents and HIV-positive patients with CD4 counts <200cells/mm^3)
- treated with any antibiotics in the 3 months prior to FMT
- GI symptoms can be explained by the presence of an underlying organic disease including, underlying inflammatory bowel disease, infectious enteritis, previously established and untreated small intestinal bacterial overgrowth or known motility disorder
- previous FMT
- severe (anaphylactic) food allergy
- unable to comply with protocol requirements
- American Society of Anesthesiologists (ASA) Physical Status classification IV and V
- acute illness or fever on the day of planned FMT will be excluded (not randomized) with the option of including that subject at a future date
- new antidepressant started or dose of antidepressant change <3 months prior to enrollment
- elevated ESR or CRP within the past 3 months
- baseline laboratory abnormalities on CBC, chemistry or liver tests
- pain score >75 on IBS-SSS
Sites / Locations
- Medical Research Center of Connecticut
- Montefiore Medical Center
- Concorde Medical Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FMT capsules
Placebo capsules
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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
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
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
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.
Satisfaction With Fecal Microbiota Transplantation (FMT)
Weekly assessments of satisfaction with the Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries.
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.
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.
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.
Patient Attitudes Towards Fecal Microbiota Transplantation (FMT)
Patient attitudes towards Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries.
Tolerability of Fecal Microbiota Transplantation (FMT)
Tolerability of Fecal Microbiota Transplantation (FMT) will be maintained in patient diaries.
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.
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.
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.
Full Information
NCT ID
NCT02328547
First Posted
December 16, 2014
Last Updated
June 20, 2019
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02328547
Brief Title
Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
Official Title
Randomized, Double-blinded, Placebo-controlled Trial of Fecal Microbiota Transplantation (FMT) for Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
fecal microbiota transplantation, diarrhea-predominant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMT capsules
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo capsules
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fecal microbiota transplantation capsules
Other Intervention Name(s)
FMT oral capsules
Intervention Description
Fecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA.
Intervention Type
Drug
Intervention Name(s)
Placebo capsules
Intervention Description
Placebo capsules prepared by OpenBiome, Medford, MA
Primary Outcome Measure Information:
Title
Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS)
Description
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.
Time Frame
Baseline, Week 12 (before cross-over), Week 24
Secondary Outcome Measure Information:
Title
Within and Between Group Comparisons of Quality of Life as Determined by the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Score
Description
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
Time Frame
Baseline, Week 12 (before cross-over), Week 24
Title
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Description
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.
Time Frame
Baseline, Week 1, Week 4 and Week 12
Title
Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety)
Description
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
Time Frame
Baseline, Week 12 (before cross-over), Week 24
Title
Depression as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression)
Description
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
Time Frame
Baseline, Week 12 (before cross-over), Week 24
Title
Bowel Consistency as Measured by the Bristol Stool Form Scale (BSFS)
Description
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
Time Frame
Baseline, Week 12 (before cross-over), Week 24
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
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.
Time Frame
All AEs over 24 weeks
Title
Satisfaction With Fecal Microbiota Transplantation (FMT)
Description
Weekly assessments of satisfaction with the Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries.
Time Frame
Week 12 following administration of FMT
Title
Change in Bowel Habits and Abdominal Pain After Fecal Microbiota Transplantation (FMT)
Description
Degree of improvement in bowel habits and abdominal pain will be recorded in patient diaries.
Time Frame
Week 12 following administration of FMT
Title
Number of Doctor or Emergency Department (ED) Visits Post-Fecal Microbiota Transplantation (Post-FMT) for Irritable Bowel Syndrome-D (IBS-D) Related Symptoms
Description
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.
Time Frame
Week 12 following administration of FMT
Title
Initiation of New Medications Post-FMT for the Treatment of IBS-D Symptoms
Description
Initiation of new medications post-FMT for the treatment of IBS-D symptoms will be recorded in patient diaries.
Time Frame
Week 12 following administration of FMT
Title
Patient Attitudes Towards Fecal Microbiota Transplantation (FMT)
Description
Patient attitudes towards Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries.
Time Frame
Week 12 following administration of FMT
Title
Tolerability of Fecal Microbiota Transplantation (FMT)
Description
Tolerability of Fecal Microbiota Transplantation (FMT) will be maintained in patient diaries.
Time Frame
Week 12 following administration of FMT
Title
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Description
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.
Time Frame
Baseline, Week 1, Week 4 and Week 12
Title
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Description
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.
Time Frame
Baseline, Week 1, Week 4 and Week 12
Title
Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)
Description
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.
Time Frame
Baseline and Week 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 19-65 years
established diagnosis of IBS-D as determined by Rome III Criteria
moderate-severe disease activity (as determined by an IBS-Symptom Severity Score ≥175)
persistent symptoms despite conventional therapy
normal colonoscopy with biopsies in the past for work-up of IBS symptoms
negative work-up for celiac disease either by duodenal biopsies or negative serologies
Exclusion Criteria:
pregnancy
nursing
cognitive impairment or severe neuropsychiatric comorbidities who are incapable of providing their own informed consent
severely immunocompromised or immunosuppressed patients (e.g., organ transplant recipients, severe neutropenia with an absolute neutrophil count of <500cells/mL, current treatment or treatment within 3 months with anti-neoplastic agents and HIV-positive patients with CD4 counts <200cells/mm^3)
treated with any antibiotics in the 3 months prior to FMT
GI symptoms can be explained by the presence of an underlying organic disease including, underlying inflammatory bowel disease, infectious enteritis, previously established and untreated small intestinal bacterial overgrowth or known motility disorder
previous FMT
severe (anaphylactic) food allergy
unable to comply with protocol requirements
American Society of Anesthesiologists (ASA) Physical Status classification IV and V
acute illness or fever on the day of planned FMT will be excluded (not randomized) with the option of including that subject at a future date
new antidepressant started or dose of antidepressant change <3 months prior to enrollment
elevated ESR or CRP within the past 3 months
baseline laboratory abnormalities on CBC, chemistry or liver tests
pain score >75 on IBS-SSS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga C Aroniadis, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence J Brandt, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Research Center of Connecticut
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Concorde Medical Group
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31326345
Citation
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.
Results Reference
derived
Learn more about this trial
Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
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