NCT05740319 Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
| NCT ID | NCT05740319 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2023-06-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2023-06-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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;
Contact & Investigator
Ling Dong
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT05740319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05740319 currently recruiting?
Yes, NCT05740319 is actively recruiting participants. Contact the research team at wu.shengdi@zs-hospital.sh.cn for enrollment information.
Where is the NCT05740319 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05740319 clinical trial?
NCT05740319 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Ling Dong at Fudan University. The trial plans to enroll 102 participants.