RecruitingNCT06730451

Microbiota Transplantation in Solid Organ Transplantation

Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation


Sponsor

The Second Hospital of Nanjing Medical University

Enrollment

50 participants

Start Date

Jan 1, 2018

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria3

  • solid organ transplantation recipients;
  • suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile) post-transplantation and so on;
  • is willing to undergo WMT and provide written informed consent.

Exclusion Criteria6

  • patients with history of gastrointestinal diseases or homologous pathogen infection pre-transplant;
  • pregnant or lactating females;
  • expected survival\<1 months;
  • 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;
  • other conditions judged by investigators not suitable for study participation.

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Interventions

OTHERWashed Microbiota Transplantation

Washed microbiota suspension delivered through mild-gut and lower-gut


Locations(1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06730451


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