Solid Organ Transplant Complications
Conditions
Keywords
Solid Organ Transplant Complications, Washed microbiota transplantation, Fecal microbiota transplantation, Diarrhea, Clostridium difficile
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.
Interventions
Washed microbiota suspension delivered through mild-gut and lower-gut
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactFaming Zhang, PhD
Outcome results
None listed