Transplanting gut bacteria to improve outcomes in organ transplant patients
Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation
This study tests whether transplanting gut bacteria can help organ transplant patients who are having stomach issues feel better and reduce complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | The Second Hospital of Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06730451 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the efficacy and safety of washed microbiota transplantation (WMT) in patients who have undergone solid organ transplantation and are experiencing gastrointestinal complications. The study focuses on restoring gut microbiome balance, which may be disrupted due to immunosuppressive therapies and antibiotics. By utilizing a new methodology for fecal microbiota transplantation, the researchers aim to address common post-transplant complications such as diarrhea and infections. Participants will be solid organ transplant recipients willing to undergo this innovative treatment.
Who should consider this trial
Good fit: Ideal candidates are solid organ transplant recipients suffering from gastrointestinal symptoms or infections post-transplant.
Not a fit: Patients with a history of gastrointestinal diseases or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of gastrointestinal complications in solid organ transplant recipients.
How similar studies have performed: While the approach of microbiota transplantation is gaining interest, this specific methodology of washed microbiota transplantation is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. solid organ transplantation recipients; 2. suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile) post-transplantation and so on; 3. is willing to undergo WMT and provide written informed consent. Exclusion Criteria: 1. patients with history of gastrointestinal diseases or homologous pathogen infection pre-transplant; 2. pregnant or lactating females; 3. expected survival\<1 months; 4. unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures; 5. follow up less than 1-month post-WMT; 6. other conditions judged by investigators not suitable for study participation.
Where this trial is running
Nanjing, Jiangsu
- The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Faming Zhang, PhD — The Second Hospital of Nanjing Medical University
- Study coordinator: Faming Zhang, 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.