Fecal microbiota transplantation for treating ulcerative colitis
Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis
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 |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Guangzhou First People's Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03804931 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with active, moderate to severe ulcerative colitis who have a Mayo score greater than 6.
Not a fit: Patients who have used antibiotics in the past 7 days or have severe comorbid conditions may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.