NCT06730451 Microbiota Transplantation in Solid Organ Transplantation
| NCT ID | NCT06730451 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Second Hospital of Nanjing Medical University |
| Condition | Solid Organ Transplant Complications |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2018-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2018-01-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Solid organ transplantation (SOT), an alternative therapy for end-stage diseases, offers increased longevity and better quantity of life. Posttransplant complications such as gastrointestinal symptoms, infection, and graft rejection increase risk with graft failure and death. However, the treatment of abovementioned complications remains unsatisfactory. Gut dysbiosis has been reported in patients with SOT, especially in patients with posttransplant complications. Recipients are more susceptible to gut dysbiosis as long-term use of immunosuppressants, antibiotics and corticosteroids. Restoring gut microbiome may be a promising therapy for posttransplant complications. Washed microbiota transplantation (WMT) is a newly improved methodology of fecal microbiota transplantation based on automatic facilities, washing process and a new delivery routine. In this study, investigators aimed to evaluate the efficacy and safety of WMT for postoperative complications in SOT.
Eligibility 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.
Contact & Investigator
Faming Zhang, PhD
PRINCIPAL INVESTIGATOR
The Second Hospital of Nanjing Medical University
Frequently Asked Questions
Who can join the NCT06730451 clinical trial?
This trial is open to participants of all sexes, studying Solid Organ Transplant Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06730451 currently recruiting?
Yes, NCT06730451 is actively recruiting participants. Contact the research team at fzhang@njmu.edu.cn for enrollment information.
Where is the NCT06730451 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06730451 clinical trial?
NCT06730451 is sponsored by The Second Hospital of Nanjing Medical University. The principal investigator is Faming Zhang, PhD at The Second Hospital of Nanjing Medical University. The trial plans to enroll 50 participants.