Clinical trial NCT06708676: Washed Microbiota Transplantation in Solid Organ Transplantation
Official title: Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Solid Organ Transplant Complications
Keywords: Solid Organ Transplant Complications
Washed microbiota transplantation
Fecal microbiota transplantation
Diarrhea
Clostridium difficile
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Stool frequency and consistency
timeFrame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
measure: Pathogen detection and culture
timeFrame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
Secondary outcomes:
measure: Adverse events(AEs)
timeFrame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT
measure: Gut microbiota
timeFrame: Baseline, 3-month post WMT
measure: Quality of life by SF-36
timeFrame: Baseline, 3-month post WMT
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Faming Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Swarte JC, Li Y, Hu S, Bjork JR, Gacesa R, Vich Vila A, Douwes RM, Collij V, Kurilshikov A, Post A, Klaassen MAY, Eisenga MF, Gomes-Neto AW, Kremer D, Jansen BH, Knobbe TJ, Berger SP, Sanders JF, Heiner-Fokkema MR, Porte RJ, Cuperus FJC, de Meijer VE, Wijmenga C, Festen EAM, Zhernakova A, Fu J, Harmsen HJM, Blokzijl H, Bakker SJL, Weersma RK. Gut microbiome dysbiosis is associated with increased mortality after solid organ transplantation. Sci Transl Med. 2022 Aug 31;14(660):eabn7566. doi: 10.1126/scitranslmed.abn7566. Epub 2022 Aug 31.
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