Fecal microbiota transplantation for ulcerative colitis treatment
Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis
This study is testing whether a new treatment using donated stool to restore gut bacteria can help people with moderate to severe ulcerative colitis feel better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 6 Years to 80 Years |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT01790061 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of standardized fecal microbiota transplantation (FMT) as a treatment for moderate to severe ulcerative colitis (UC). The study involves isolating specific gut bacteria from donated stool and transplanting them into the mid-gut of patients using a gastroscope. Participants will be assigned to receive either FMT or traditional treatments, with follow-up data collected over time to assess outcomes. The trial aims to restore gut functionality and improve symptoms associated with UC.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with moderate to severe ulcerative colitis who have not achieved satisfactory results from previous treatments.
Not a fit: Patients with other severe diseases or intestinal conditions, such as Clostridioides difficile infection, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with moderate to severe ulcerative colitis who have not responded to conventional therapies.
How similar studies have performed: Preliminary studies have shown some success with fecal microbiota transplantation for ulcerative colitis, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients who had been diagnosed with UC through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, and patients who failed to achieve satisfactory efficacy for UC from the previous therapies. Exclusion Criteria: Patients were excluded if accompanied by other severe diseases, including other intestinal diseases (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure, and serious liver and kidney disease, refused to complete the follow-up, and underwent FMT or WMT before.
Where this trial is running
Nanjing, Jiangsu
- Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Faming Zhang, MD,PhD
- Email: fzhang@njmu.edu.cn
- Phone: 086-25-58509883
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.