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

NCT ID: NCT07149441

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2028-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biological agent +FMT

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.

Group Type: EXPERIMENTAL

Fecal microbiota transplantation

Intervention Type: 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.

infliximab

Intervention Type: DRUG

Intravenous infusion of infliximab once every 8 weeks.

Biological agent

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.

Group Type: EXPERIMENTAL

infliximab

Intervention Type: DRUG

Intravenous infusion of infliximab once every 8 weeks.

Interventions

Fecal microbiota transplantation

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.

Intervention Type: PROCEDURE

infliximab

Intravenous infusion of infliximab once every 8 weeks.

Intervention Type: DRUG

Other Intervention Names

Biological agent

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen QiYi

Director of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FMT-IBD

Identifier Type: -

Identifier Source: org_study_id