Using fecal microbiota transplantation to treat severe intestinal infections
Official title: Rescue Fecal Microbiota Transplantation for Refractory Intestinal Infections: China National Registry
Run by The Second Hospital of Nanjing Medical University · NCT03895593 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | September 25, 2015 |
| Main results expected | May 1, 2024 |
| Study ends | May 1, 2029 |
| Registry record updated | February 29, 2024 |
| Trial ID | NCT03895593 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are national patients suffering from refractory intestinal infections who are receiving rescue FMT from the China Microbiota Transplantation System.
✕Probably not a fit
Patients who do not complete at least 12 weeks of follow-up post-FMT will 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 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.
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 gone: Previous studies have shown promise with fecal microbiota transplantation for similar conditions, indicating a potential for success with this approach.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Diet and counseling to see how meals affect gut health after CDI
We’re testing whether different meal plans and health counseling can influence the gut microbiome and reduce chances of CDI coming back in adults who are being treated for CDI.
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Lyophilized fecal microbiota transplant for adults with active ulcerative colitis
This trial will test whether a dried (lyophilized) fecal microbiota transplant helps adults with active ulcerative colitis when added to their current treatment or started alongside a new advanced medication.
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How antibiotics versus fecal transplants affect recovery from C. difficile infection
This project will see how antibiotics and fecal microbiota transplant (FMT) affect adults with C. difficile infection by tracking recovery and biological changes over time.
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This will try a single dose of the antibody AZD5148 versus placebo to see if it prevents repeat C. difficile infections in adults being treated for a current infection.
-
Preventing C. difficile recurrence with short-course oral vancomycin during later antibiotics
This trial tests whether taking short-course oral vancomycin while you need systemic antibiotics can prevent a recurrence of C. difficile in adults recently treated for CDI.
-
UDCA added to standard therapy to prevent C. diff recurrence
This study tests whether taking ursodeoxycholic acid alongside standard antibiotics can reduce recurrence of C. difficile colitis in adults at risk.
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.