Donor Selection for Faecal Microbiota Transplantation in Irritable Bowel Syndrome

Launched by HAUKELAND UNIVERSITY HOSPITAL · Dec 6, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how the choice of donor affects the success of fecal microbiota transplantation (FMT) for patients with Irritable Bowel Syndrome (IBS). In this study, 200 participants will be randomly assigned to receive either their own feces (placebo) or a transplant from one of three different donors. The procedure involves delivering the fecal transplant into the upper part of the intestines using a gastroscope, which is a thin, flexible tube. Throughout the trial, participants will fill out questionnaires about their symptoms and quality of life and provide stool samples at various points to help researchers understand how the treatment is working.

To be eligible for this trial, participants must meet certain criteria, including having moderate to severe IBS symptoms and no other gastrointestinal issues. They should not have taken antibiotics or probiotics recently, nor can they be pregnant or have serious health conditions like kidney failure or diabetes. Participants can expect to be closely monitored over the course of the trial, with regular assessments of their health and symptoms. This trial is not yet recruiting, but it aims to provide important insights into how donor selection might influence the effectiveness of fecal transplants for IBS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients who fulfil Rome IV criteria for the
• • diagnosis of IBS.
• • Patients were investigated to exclude other
• • gastrointestinal organic cause(s).
• • Moderate-to-severe IBS symptoms, as indicated
• • by a score of ≥175 on the IBS-SSS questionnaire
• Exclusion Criteria:
• • Pregnant, women planning pregnancy or lactating women.
• • The use of antibiotics or probiotics within 1
• • month prior to FMT.
• • Having undergone any abdominal surgery, with
• • the exception of appendectomy, cholecystectomy,
• • caesarean section and hysterectomy.
• • Previous treatment with FMT.
• • Immunocompromised patients including those being
• • treated by immunosuppressive medications.
• • Patients with co-morbidity such as kidney failure,
• • diabetes or chronic heart disease.
• • Patients with serious psychiatric disorders
• • or alcohol or drug abuse.