An observational study in Solid Organ Transplant Complications, sponsored by The Second Hospital of Nanjing Medical University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by The Second Hospital of Nanjing Medical University · Observational
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.
865 studies on the registry are indexed under Diarrhea; 77 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 109 observational studies indexed under Diarrhea.
Browse Diarrhea studies →The Second Hospital of Nanjing Medical University is the lead sponsor of 70 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Solid organ transplantation recipients receiving WMT will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Washed microbiota suspension delivered through mild-gut and lower-gut
Stool frequency and consistency
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.
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
The changes in gut microbiota composition by sequencing faecal metagenome
The changes in gut microbe composition before and after WMT were evaluated by sequencing faecal metagenome.
Time frame: Baseline, 1-month, 3-month post WMT
Quality of life by 36-Item Short Form Health Survey(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, and mental health) ranging from 0 to 100. Lower scores represent more dysfunction.
Time frame: Baseline, 1-month, 3-month post WMT
Plan to share: No
Started Jan 2018 (actual). Primary completion is estimated for Dec 2027, 119 months after the start.
Of 39 non-industry observational studies under Diarrhea, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 119 months is above that.
Counting every sponsor, half of 45 studies reached it within 26 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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The Second Hospital of Nanjing Medical University