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Clinical Trials in China / NCT07149441
Active, not recruiting Not applicable

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

NCT07149441 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai 10th People's Hospital
Phase
Not applicable
Started
2025-08-01
Last updated
2025-09-02

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Fecal microbiota transplantationinfliximab →

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.

infliximab: Intravenous infusion of infliximab once every 8 weeks.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Endoscopic remission rate — 14th and 52nd week after joining the group.
    UC is endoscopic Mayo score 0-1; CD is simple endoscopic score (SES-CD)\<3 or no ulcer.
  • Clinical remission rate — 14th and 52nd week after joining the group.
    UC is defined as Mayo score ≤2, and no single score \> 1; CD is defined as CDAI (Crohn's disease activity index) \< 150.

Trial sites (1)

FacilityCityRegionStatus
Shanghai Tenth People's Hospital Shanghai Shanghai Municipality

On this site

📄 Remicade (infliximab) drug profile →

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Other trials for the same condition

Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA) Recruiting
Fecal Microbiota Transplantation for the Treatment of Refractory Hepatic Encephalopathy After TIPS Surgery Recruiting
Efficacy and Safety of Fecal Microbiota Transplantation Recruiting
Fecal Microbiota Transplantation for Ulcerative Colitis Recruiting
Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease Active, not 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 NCT07149441 on ClinicalTrials.gov ↗ ← All trials in China