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

NCT05740319 | Recruiting

• 1 other identifier: B2022-507R
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Change from baseline IBS symptom severity scale (IBS-SSS) score at 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).

  at baseline and 9 weeks

• Response rate 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".

  at 9 weeks

Secondary Outcomes (8)

• Change from baseline IBS symptom severity scale (IBS-SSS) score at 1 week, 1 month and 6 months

  at baseline, 1 week, 1 month and 6 months

• Change from baseline Gastrointestinal Symptom Rating Scale (GSRS) score at 1 week, 1 month, 9 weeks and 6 months

  at baseline, 1 week, 1 month, 9 weeks and 6 months

• Change from baseline IBS-Quality of Life (IBS-QoL) score at 1 month, 3 months and 6 months

  at baseline, 1 month, 3months and 6 months

• Change from baseline Self-rating Anxiety Scale (SAS) score at 1 month, 3 months and 6 months

  at baseline, 1 month, 3months and 6 months

• Change from baseline Self-rating Depression Scale (SDS) score at 1 month, 3 months and 6 months

  at baseline, 1 month, 3months and 6 months

Study Arms (1)

FMT

EXPERIMENTAL

Participants will be given FMT through oral capsules or nasojejunal tube once a month for three months.

Other: FMT

Interventions

FMT OTHER

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

FMT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Ling Dong

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengdi Wu

CONTACT

(86)13817923359; wu.shengdi@zs-hospital.sh.cn

Ling Dong

CONTACT

(86)13916877798; dong.ling@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 23, 2023
• Study Start: June 10, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)