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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Washed microbiota suspension delivered through mild-gut and lower-gut
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Stool frequency and consistency
Stool frequency and consistency will be evaluated according to the Bristol Stool Form Scale (BSFS, ranging from type 1 - type 7)
Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Gastrointestinal Symptom Rating Scale (GSRS)
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).
Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Pathogen detection and culture
Pathogen was detected and cultured from serum, urine, stool and so on before and after WMT.
Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Adverse events(AEs)
AEs will be evaluated according to NCI Common Terminology Criteria for Adverse Events(CTCAE), Version 5.0
Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Gut microbiota
Changes in intestinal microbial composition and diversity in the stool samples of patients before and after WMT
Time frame: Baseline, 3-month post WMT
Quality of life by SF-36
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.
Time frame: Baseline, 3-month post WMT
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