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Clinical Trials in China / NCT05740319
Recruiting Not applicable

Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome

NCT05740319 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Not applicable
Started
2023-06-10
Last updated
2026-02-25

Condition(s) studied

Irritable Bowel Syndrome

Investigational drug(s) / intervention(s)

FMT

FMT: FMT refers to transplanting healthy donor-derived microbiota to participants via oral capsule or injection of fecal suspension via nasojejunal tube.

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Criteria: * 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;

Primary outcome measure(s)

  • Change from baseline IBS symptom severity scale (IBS-SSS) score at 9 weeks — at baseline and 9 weeks
    IBS symptom severity scale (IBS-SSS) is used to evaluate change in IBS symptoms, with a score ranging from 0 to 500. Higher score means severer IBS symptom. Change in IBS-SSS score is obtained by evaluating the scale at baseline and 9 weeks (after three-time FMT).
  • Response rate at 9 weeks — at 9 weeks
    Investigator ask participants a single question, "Compared to the way you felt before you entered the study, have you IBS symptoms over the past 7 days been: 1)"Substantially Worse"; 2)"Moderately Worse"; 3) Slightly Worse; 4)"No Change"; 5) Slightly Improved"; 6) Moderately Improved"; 7) Substantially Improved". Responder is defined as participants who report "moderately improved" or "substantially improved".

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting

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Other trials for the same condition

Fecal Microbiota Transplantation for Irritable Bowel Syndrome Recruiting
Efficacy of Probiotics in Patients With IBD Recruiting
Efficacy of Esketamine for Patients With Irritable Bowel Syndrome Recruiting
Analysis of Differences in Small Intestinal Microbiota Structure and Metabolites Between Patients With Irritable Bowel Syndrome and Healthy Individuals Starting soon
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05740319 on ClinicalTrials.gov ↗ ← All trials in China