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
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Guangzhou First People's Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | January 20, 2019 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2030 |
| Registry record updated | January 15, 2019 |
| Trial ID | NCT03804931 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
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Innovative Multidisciplinary and Virtual Care for IBD in Pregnancy
This study tests a dedicated IBD pregnancy care model, including a new virtual approach, to see if it improves access and quality of care for pregnant people with Crohn's disease or ulcerative colitis.
-
A Probiotic Approach to Modulating Gut Microbiota in Mild-to-Moderate Ulcerative Colitis
A specific probiotic given rectally will be tested in adults with mild-to-moderate ulcerative colitis to see if it can help manage symptoms.
-
Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults
This study tests combinations of risankizumab with either trosunilimab or ABBV-701 in adults with moderately to severely active Crohn's disease or ulcerative colitis.
-
Fecal transplant plus standard therapy for refractory hepatic encephalopathy after TIPS
This study tests whether adding fecal microbiota transplantation to usual medicines helps people with recurrent hepatic encephalopathy after TIPS implant.
-
Longitudinal Immunophenotyping of People with Inflammatory Bowel Disease
This study will follow adults with Crohn's disease or ulcerative colitis (and some healthy relatives) over three years to see how their immune cells change over time and how genetics and diet relate to their disease.
-
High Protein, High Fiber Diet for Ulcerative Colitis
This study tests a high-protein, high-fiber diet to see if it helps people with ulcerative colitis by meeting protein needs and lowering harmful hydrogen sulfide production in the gut.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.