Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
Shanghai Zhongshan Hospital
102 participants
Jun 10, 2023
INTERVENTIONAL
Conditions
Summary
Participants will be given FMT through oral capsules or nasojejunal tube once a month. After three-time treatment, participants were followed up for three months. Participants complete specific scales to assess improvement in symptoms, emotion and quality of life. Besides, they report adverse effects and collect fecal samples at each visit.
Eligibility
Inclusion Criteria3
- Patients who fulfilled the Rome IV criteria for the diagnosis of IBS, aged 18-70 years;
- Patients who have experienced failure of at least 3 conventional therapies for IBS;
- Absence of red flags such as weight loss, hematochezia;
Exclusion Criteria7
- Pregnant, planning pregnancy or lactating;
- Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
- Immunodeficiency or treatment with immune-modulating medication;
- Use of probiotics within the previous 3 months or treatment with antibiotics within 1 month prior to study entry;
- Having undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
- Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease;
- Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
FMT refers to transplanting healthy donor-derived microbiota to participants via oral capsule or injection of fecal suspension via nasojejunal tube.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05740319