Fecal Microbiota Transplantation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Intervention: Fecal microbiota transplantation capsules; Placebo capsules
Intervention description: Fecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA.; Placebo capsules prepared by OpenBiome, Medford, MA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: fecal microbiota transplantation; diarrhea-predominant

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 <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