Washed Microbiota Transplantation in Solid Organ Transplantation (NCT06708676) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Washed Microbiota Transplantation in Solid Organ Transplantation
China50 participantsStarted 2024-11-20
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. solid organ transplantation recipients;
. suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile, urinary infection) post-transplantation, graft rejection and so on;
. is willing to undergo WMT and provide written informed consent;
Exclusion criteria
. patients with history of gastrointestinal diseases or homologous pathogen infection pre-transplant;
. pregnant or lactating females;
. unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures;
. follow up less than 1-month post-WMT;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stool frequency and consistency
Timeframe: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
2
Gastrointestinal Symptom Rating Scale (GSRS)
Timeframe: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
3
Pathogen detection and culture
Timeframe: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Trial details
NCT IDNCT06708676
SponsorThe Second Hospital of Nanjing Medical University