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NCT Number: NCT06708676

Washed Microbiota Transplantation 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.

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Key information

Conditions

Solid Organ Transplant Complications Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • other conditions judged by investigators not suitable for study participation;

Treatment and study plan

washed microbiota transplantation

Other

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

Other names: fecal microbiota transplanatation

Primary outcomes

  1. 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)

  2. 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).

  3. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Faming Zhang, PhD

CONTACT

[email protected]

086-25-58509883

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Registry information

Official study title

Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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