Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07149441

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis) Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Fecal Microbiota Transplantation Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Infliximab

Drug

Intravenous infusion of infliximab once every 8 weeks.

Other names: Biological agent

Primary outcomes

  1. Endoscopic remission rate

    Time frame: 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.

  2. Clinical remission rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.