Microbiota Transplantation in Solid Organ Transplantation

The Second Hospital of Nanjing Medical University50 enrolled

Overview

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

OBSERVATIONAL

Enrollment

Conditions

Solid Organ Transplant Complications

Interventions

Washed Microbiota TransplantationOTHER

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. solid organ transplantation recipients; 2. suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile) post-transplantation 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. expected survival\<1 months; 4. unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures; 5. follow up less than 1-month post-WMT; 6. other conditions judged by investigators not suitable for study participation.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.