Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Minnesota
Mayo Clinic in Minnesota
RECRUITING
Rochester
Contact Information
Primary
Jonah Pedelty, MS
pedelty.jonah@mayo.edu
507-538-7774
Backup
Margaret Breen-Lyles
breen-lyles.margaret@mayo.edu
507-422-5759
Time Frame
Start Date: 2024-04-15
Estimated Completion Date: 2025-09
Participants
Target number of participants: 43
Treatments
Experimental: Donor Fecal Microbiota Transplantation Group
Subjects will receive a fecal microbiota transplantation (FMT) using stool from a donor
Placebo_comparator: Autologous Fecal Microbiota Transplantation Group
Subjects will receive a fecal microbiota transplantation (FMT) using their own stool
Related Therapeutic Areas
Sponsors
Leads: Madhusudan (Madhu) Grover, MBBS