Efficacy and Mechanism of FMT in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study

NCT07149441 | Active Not Recruiting

• 1 other identifier: FMT-IBD
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This study enrolled 94 patients with UC or CD. Two groups received either 8-week intestinal bacterial transplant capsule therapy or biological therapy, respectively. The control group received biological therapy alone, while the experimental group received biological therapy combined with FMT. Both groups were followed up for 52 weeks after discharge. The efficacy of FMT capsule therapy on the subjects' UC or CD symptom-related scores and its effect on remodeling the intestinal flora were observed, and its safety was verified.

Conditions

Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis); Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (2)

• Endoscopic remission rate

  UC is endoscopic Mayo score 0-1; CD is simple endoscopic score (SES-CD)\<3 or no ulcer.

  14th and 52nd week after joining the group.

• Clinical remission rate

  UC is defined as Mayo score ≤2, and no single score \> 1; CD is defined as CDAI (Crohn's disease activity index) \< 150.

  14th and 52nd week after joining the group.

Study Arms (2)

Biological agent +FMT

EXPERIMENTAL

47 patients were treated with biological agents combined with fecal microbiota transplants (FMT). All patients were followed up for 52 weeks after discharge. To observe the curative effect of FMT capsule treatment on UC or CD symptom-related scores of subjects and its remodeling effect on intestinal flora and verify its safety.

Procedure: Fecal microbiota transplantation; Drug: infliximab

Biological agent

EXPERIMENTAL

47 patients were treated with biological agents. All patients were followed up for 52 weeks after discharge. To observe the curative effect of FMT capsule treatment on UC or CD symptom-related scores of subjects and its remodeling effect on intestinal flora and verify its safety.

Drug: infliximab

Interventions

Fecal microbiota transplantation PROCEDURE

Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota.

Biological agent +FMT

infliximab DRUG

Intravenous infusion of infliximab once every 8 weeks.

Also known as: Biological agent

Biological agent; Biological agent +FMT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence.
• IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases.
• Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449)
• Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved.
• Voluntary participation and signing of informed consent.
• Adults aged 18-65.
• Can tolerate oral enterobacteria transplantation capsule treatment.

You may not qualify if:

• The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence.
• IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases.
• Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449)
• Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved.
• Voluntary participation and signing of informed consent.
• Adults aged 18-65.
• Can tolerate oral enterobacteria transplantation capsule treatment.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation; Infliximab; Biological Factors

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)