Fecal Microbiota Transplantation for IBS
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorMadhusudan (Madhu) Grover, MBBS
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Donor Fecal Microbiota Transplantation
- Autologous Fecal Microbiota Transplantation
Treatment groups
43 Participants
are divided into 2 treatment groupsLocations
1Mayo Clinic in Minnesota55905, RochesterMinnesota, United States
Sponsors and collaborators
Madhusudan (Madhu) Grover, MBBS
Lead sponsor
Mayo Clinic
Sponsor institution
Source ClinicalTrials.gov