Using fecal microbiota transplantation to treat severe intestinal infections
Rescue Fecal Microbiota Transplantation for Refractory Intestinal Infections: China National Registry
This study is testing whether a new way of using fecal transplants can help people with severe intestinal infections, like C. difficile, feel better and recover.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT03895593 on ClinicalTrials.gov |
What this trial studies
This observational registry collects data from patients across China who are receiving rescue fecal microbiota transplantation (FMT) for refractory intestinal infections, including Clostridioides difficile infection. The study utilizes a novel approach called washed microbiota transplantation (WMT), which involves an improved methodology for preparing the fecal microbiota. Data on patient demographics, symptoms, previous treatments, and clinical outcomes will be gathered from medical records and follow-ups over a minimum of 12 weeks post-FMT. The aim is to evaluate both the short-term and long-term safety and efficacy of this treatment.
Who should consider this trial
Good fit: Ideal candidates are national patients suffering from refractory intestinal infections who are receiving rescue FMT from the China Microbiota Transplantation System.
Not a fit: Patients who do not complete at least 12 weeks of follow-up post-FMT will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with difficult-to-treat intestinal infections.
How similar studies have performed: Previous studies have shown promise with fecal microbiota transplantation for similar conditions, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: National patients with refractory intestinal infections receiving rescue FMT from the China Microbiota Transplantation System from September 2015 to December, 2029 will be included. \- Exclusion Criteria: Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT. \-
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
- Principal investigator: faming zhang, MD,PhD — The Second Hospital of Nanjing Medical University
- Study coordinator: faming zhang, MD,PhD
- Email: fzhang@njmu.edu.cn
- Phone: 086-025-58509883
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.