Washed Microbiota Transplantation in Solid Organ Transplantation

Not Applicable

Not yet recruiting

• Conditions: Solid Organ Transplant Complications

• Registration Number: NCT06708676
• Lead Sponsor: The Second Hospital of Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-20
• Study First Submitted: 2024-11-24
• Study First Submitted QC: 2024-11-24
• Last Update Submitted: 2024-11-24
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2029-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stool frequency and consistency	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)
Gastrointestinal Symptom Rating Scale (GSRS)	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).
Pathogen detection and culture	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 Outcome Measures

Name	Time	Method
Adverse events(AEs)	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
Gut microbiota	Baseline, 3-month post WMT	Changes in intestinal microbial composition and diversity in the stool samples of patients before and after WMT
Quality of life by SF-36	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.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China