Washed Microbiota Transplantation in Solid Organ Transplantation

November 24, 2024 updated by: Faming Zhang, The Second Hospital of Nanjing Medical University

Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • The Second Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Washed Microbiota Transplantation(WMT)
Other: Washed Microbiota Transplantation
Washed microbiota suspension delivered through mild-gut and lower-gut
Other Names:
  • fecal microbiota transplanatation
No Intervention: Basic Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool frequency and consistency
Time Frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Stool frequency and consistency will be evaluated according to the Bristol Stool Form Scale (BSFS, ranging from type 1 - type 7)
Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Gastrointestinal Symptom Rating Scale (GSRS)
Time Frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).
Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Pathogen detection and culture
Time Frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Pathogen was detected and cultured from serum, urine, stool and so on before and after WMT.
Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events(AEs)
Time Frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
AEs will be evaluated according to NCI Common Terminology Criteria for Adverse Events(CTCAE), Version 5.0
Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Gut microbiota
Time Frame: Baseline, 3-month post WMT
Changes in intestinal microbial composition and diversity in the stool samples of patients before and after WMT
Baseline, 3-month post WMT
Quality of life by SF-36
Time Frame: Baseline, 3-month post WMT
SF-36 is a 36-item questionnaire to assess the impact of disease on daily life. The SF-36 consists of 8 subscales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health). Lower scores represent more dysfunction.
Baseline, 3-month post WMT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Nanjing Medical University

Investigators

  • Principal Investigator: Faming Zhang, PhD, The Second Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 20, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

November 24, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 24, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WMT-SOT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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