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NCT Number: NCT06730451

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

Observational

Primary location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Faming Zhang, PhD

CONTACT

[email protected]

025-25-58509883

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) post-transplantation 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;
  • 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.

Treatment and study plan

washed microbiota transplantation

Other

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

Primary outcomes

  1. Stool frequency and consistency

    Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT

    Stool frequency ≥3 times per day was considered as diarrhea. Higher frequency represents more severe diarrhea. Stool consistency will be evaluated according to the Bristol Stool Form Scale ranging from type 1 - type 7. Type 1 and 2 indicate constipation, Type 3 and type 4 indicate normal defecation, Type 5, 6 and 7 indicate diarrhea.

  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).

Secondary outcomes

  1. The changes in gut microbiota composition by sequencing faecal metagenome

    Time frame: Baseline, 1-month, 3-month post WMT

    The changes in gut microbe composition before and after WMT were evaluated by sequencing faecal metagenome.

  2. Quality of life by 36-Item Short Form Health Survey(SF-36)

    Time frame: Baseline, 1-month, 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, and mental health) ranging from 0 to 100. 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

Collaborators

  • The Chinese fmtBank

Registry information

Official study title

Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Dec 12, 2024
Registry last updated
Dec 12, 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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