Phase 2
Completed N=48
Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
Source: ClinicalTrials.gov NCT02328547 ↗Enrolled (actual)
48
Serious AEs
1.0%
Results posted
Jul 2019
Primary outcomePrimary: 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
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.
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) |
— | — |
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. Informational only — not medical advice.