Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Percentage of responders
Study Overview
Brief Summary
The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •IBS defined by Rome IV criteria
- •Non IBS-C
- •Moderate to severe symptoms defined by IBS-SSS≥175
- •Able to safely undergo and consent to colonoscopy
Exclusion Criteria
- •Immune deficiency or treatment with immunosuppressive medications
- •Severe bowel or medical disease precluding administration of bowel prep
- •Severe bowel or medical disease precluding colonoscopy with conscious sedation
- •Active cancer
- •Pregnant or lactating
- •Abdominal surgery (exception of splenectomy, partial hepatectomy, partial/unilateral nephrectomy, laparoscopy, pelvic floor repair, mesh, liposuction, fundoplication, tubal ligation, gastric sleeve, oophorectomy, hernia, appendectomy, cholecystectomy, caesarean section and hysterectomy)
- •Severe psychiatric disorder (HADS-A or D>16), or diagnosed alcohol or drug abuse disorder
- •New probiotics or treatment with antibiotics, NSAIDs (within 4 wks prior to study entry)
- •Use of treatments known to affect colonic motility (with exception of loperamide)
- •Diagnosed h/o bleeding disorder
- •Organic GI diseases (IBD, celiac disease, microscopic colitis)
- •Chronic kidney or liver disease
- •Absolute neutrophil count (ANC) <500 IU/ml
Arms & Interventions
Donor Fecal Microbiota Transplantation Group
Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor
Intervention: Donor Fecal Microbiota Transplantation (Biological)
Autologous Fecal Microbiota Transplantation Group
Subjects will receive a fecal microbiota transplantation (FMT) using their own stool
Intervention: Autologous Fecal Microbiota Transplantation (Biological)
Outcomes
Primary Outcomes
Percentage of responders
Time Frame: 12 weeks
Number of subjects receiving the donor fecal microbiota transplantation identified as a responder defined as a decrease of ≥50 points in Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) from baseline. The Irritable Bowel Syndrome Symptom Severity Score scale has a possible range of scores from 0-500. Mild cases are classified as a score of 75-175, moderate cases are classified as a score of 175-300, and severe cases are classified as a score of \>300.
Secondary Outcomes
- Changes in in vivo excretion of 2-24 hr lactulose excretion(Baseline, 12 weeks)
- Change in level of fecal proteolytic activity(Baseline, 12 weeks)
- Global Adequate Relief Questionnaire(12 weeks)
- Number of weekly responders(12 weeks)
- Alistipes putredinis proportion post-FMT(12 weeks)
Investigators
Madhusudan (Madhu) Grover, MBBS
Regulatory Sponsor and Principal Investigator
Mayo Clinic