Washed Microbiota Transplantation in Solid Organ Transplantation

Nanjing Medical University

Status: Not yet enrolling

Conditions: Solid Organ Transplant Complications

Treatments: Other: Washed Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06708676

WMT-SOT

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. solid organ transplantation recipients;
2. suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile, urinary infection) post-transplantation, graft rejection 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. unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures;
4. follow up less than 1-month post-WMT;
5. other conditions judged by investigators not suitable for study participation;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Washed Microbiota Transplantation(WMT)

Experimental group

Treatment:

Other: Washed Microbiota Transplantation

Basic Treatment

No Intervention group