Clinical trial NCT06730451: Microbiota Transplantation in Solid Organ Transplantation
Official title: Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solid Organ Transplant Complications
Keywords: Solid Organ Transplant Complications
Washed microbiota transplantation
Fecal microbiota transplantation
Diarrhea
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: The Chinese fmtBank
First posted: 2024-12-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Solid organ transplantation recipients receiving WMT will be enrolled.

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) 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.

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
Secondary outcomes:
measure: The changes in gut microbiota composition by sequencing faecal metagenome
timeFrame: Baseline, 1-month, 3-month post WMT
measure: Quality of life by 36-Item Short Form Health Survey(SF-36)
timeFrame: Baseline, 1-month, 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: Cheng YW, Phelps E, Ganapini V, Khan N, Ouyang F, Xu H, Khanna S, Tariq R, Friedman-Moraco RJ, Woodworth MH, Dhere T, Kraft CS, Kao D, Smith J, Le L, El-Nachef N, Kaur N, Kowsika S, Ehrlich A, Smith M, Safdar N, Misch EA, Allegretti JR, Flynn A, Kassam Z, Sharfuddin A, Vuppalanchi R, Fischer M. Fecal microbiota transplantation for the treatment of recurrent and severe Clostridium difficile infection in solid organ transplant recipients: A multicenter experience. Am J Transplant. 2019 Feb;19(2):501-511. doi: 10.1111/ajt.15058. Epub 2018 Aug 31.
citation: Swarte JC, Douwes RM, Hu S, Vich Vila A, Eisenga MF, van Londen M, Gomes-Neto AW, Weersma RK, Harmsen HJM, Bakker SJL. Characteristics and Dysbiosis of the Gut Microbiome in Renal Transplant Recipients. J Clin Med. 2020 Feb 1;9(2):386. doi: 10.3390/jcm9020386.
citation: Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.
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