Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 18 to 65

Fecal microbiota transplantation for treating ulcerative colitis

Official title: Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis

Run by Guangzhou First People's Hospital · NCT03804931 · Data updated 2026-11-12

This study is testing whether fecal microbiota transplantation can help people with moderate to severe ulcerative colitis feel better by restoring a healthy gut.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment120 (estimated)
SponsorGuangzhou First People's Hospital
Academic / other
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedJanuary 20, 2019
Main results expectedDecember 31, 2028
Study endsDecember 31, 2030
Registry record updatedJanuary 15, 2019
Trial IDNCT03804931 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals with active, moderate to severe ulcerative colitis who have a Mayo score greater than 6.

Probably not a fit

Patients who have used antibiotics in the past 7 days or have severe comorbid conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of fecal microbiota transplantation (FMT) as a treatment for patients with moderate to severe ulcerative colitis. The study involves infusing a fecal suspension from healthy donors into the intestines of participants to restore a healthy gut microbiome. Patients will receive FMT at least twice, with follow-up assessments conducted over a minimum of three months to evaluate the treatment's efficacy and safety. The trial is conducted at Guangzhou First People's Hospital, where a standardized microbiota isolation process is employed.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from ulcerative colitis.

How similar studies have gone: Previous studies have shown promising results for fecal microbiota transplantation in various gastrointestinal conditions, but its efficacy specifically for ulcerative colitis is still being explored.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Active, moderate to severe severity (Mayo score more than 6)
* Safety using history of 5-ASA
* Able to undergo endoscopy examination

Exclusion Criteria:

* Antibiotic using in 7 days
* High risk of toxic megacolon
* Colon cancer or neoplasia in pathophysiology
* Other severe diseases (eg: cardiovascular, respiratory, gastroenteral and kidney diseases)

Where it's running

  • Guangzhou First People's Hospital
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

  • Principal investigator: Yuqiang Nie, MD — Guangzhou First People's Hospital
  • Study coordinator: Hongli Huang, MM
  • Email: honglisums@126.com
  • Phone: 86-13631316718

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.