Phase 2
N=48
Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02328547 ↗Enrolled (actual)
48
Serious AEs
1.0%
Results posted
Jul 2019
Primary outcome: Primary: Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS) — 282; 309; 221; 236 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fecal microbiota transplantation capsules (Drug); Placebo capsules (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS) |
282; 309; 221; 236; 208; 157 | — |
| SECONDARY Within and Between Group Comparisons of Quality of Life as Determined by the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Score |
53; 52; 65; 66; 70; 76 | — |
| SECONDARY Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) |
0.12; 0.04; 0.14; 0.03 | — |
| SECONDARY Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety) |
8.3; 7.2; 8.6; 7.4; 7.9; 5.6 | — |
| SECONDARY Depression as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression) |
4.6; 5.1; 4.0; 4.0; 3.8; 3.4 | — |
| SECONDARY Bowel Consistency as Measured by the Bristol Stool Form Scale (BSFS) |
5; 6; 4; 5; 4; 4 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
23; 24; 25; 24 | — |
| SECONDARY Satisfaction With Fecal Microbiota Transplantation (FMT) |
— | — |
| SECONDARY Change in Bowel Habits and Abdominal Pain After Fecal Microbiota Transplantation (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 |
— | — |
| SECONDARY Initiation of New Medications Post-FMT for the Treatment of IBS-D Symptoms |
— | — |
| SECONDARY Patient Attitudes Towards Fecal Microbiota Transplantation (FMT) |
— | — |
| SECONDARY Tolerability of Fecal Microbiota Transplantation (FMT) |
— | — |
| SECONDARY Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) |
0.12; 0.04; 0.14; 0.03 | — |
| SECONDARY Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) |
0.12; 0.04; 0.14; 0.03 | — |
| SECONDARY Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation) |
0.12; 0.04; 0.14; 0.03 | — |
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.
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 75 on IBS-SSS
Data sourced from ClinicalTrials.gov (NCT02328547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.