National registry for fecal microbiota transplantation
Fecal Microbiota Transplant National Registry
This study is setting up a national registry to track how safe and effective fecal microbiota transplants are for patients with gut issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06262451 on ClinicalTrials.gov |
What this trial studies
This study establishes a national data registry for patients undergoing fecal microbiota transplantation (FMT) and other gut-related microbiota products. It aims to prospectively evaluate the short and long-term safety and effectiveness of these treatments by collecting data from patient and donor medical records, as well as research records. The study will not enroll neonates and will focus on individuals who can provide informed consent and have access to communication tools. Data will be gathered from various sources, including patient visits and phone calls.
Who should consider this trial
Good fit: Ideal candidates include adults who are receiving FMT or other gut-related microbiota products and can provide informed consent.
Not a fit: Patients who are incarcerated will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of the safety and effectiveness of FMT, leading to improved treatment protocols for patients.
How similar studies have performed: Other studies have shown promise in utilizing registries for tracking the outcomes of FMT, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Recipient Inclusion Criteria : * Ability to give informed consent * Receiving FMT or other gut-related microbiota product within 90 days after providing consent * Access to internet and/or telephone Donor Inclusion Criteria: * Ability to give informed consent * Providing stool sample for FMT Exclusion Criteria: * Incarceration
Where this trial is running
San Francisco, California
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Max Brondfield, MD — University of California, San Francisco
- Study coordinator: Rachael Leigh Delacruz
- Email: rachaelleigh.delacruz@ucsf.edu
- Phone: 4155148087
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.