Washed Microbiota Transplantation in Solid Organ Transplantation

Official title

Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation

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.

Interventions

• Other Washed Microbiota Transplantation
  Washed microbiota suspension delivered through mild-gut and lower-gut

Primary outcome measures

• Stool frequency and consistency [Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT]
• Gastrointestinal Symptom Rating Scale (GSRS) [Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT]
• Pathogen detection and culture [Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT]

Secondary outcome measures (3)

• Adverse events(AEs) [Time frame: Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT]
• Gut microbiota [Time frame: Baseline, 3-month post WMT]
• Quality of life by SF-36 [Time frame: Baseline, 3-month post WMT]

Eligibility criteria

Inclusion criteria

• solid organ transplantation recipients;
• suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile, urinary infection) post-transplantation, graft rejection and so on;
• is willing to undergo WMT and provide written informed consent;

Exclusion criteria

• patients with history of gastrointestinal diseases or homologous pathogen infection pre-transplant;
• pregnant or lactating females;
• unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures;
• follow up less than 1-month post-WMT;
• other conditions judged by investigators not suitable for study participation;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Second Affiliated Hospital of Nanjing Medical University — Nanjing

Publications

• Lu G, Wang W, Li P, Wen Q, Cui B, Zhang F. Washed preparation of faecal microbiota changes the transplantation related safety, quantitative method and delivery. Microb Biotechnol. 2022 Sep;15(9):2439-2449. doi: 10.1111/1751-7915.14074. Epub 2022 May 16. PMID 35576458
• 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. PMID 31919742
• 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. PMID 32024079
• 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 infecti PMID 30085388
• 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 m PMID 36044594
• Lee JR, Magruder M, Zhang L, Westblade LF, Satlin MJ, Robertson A, Edusei E, Crawford C, Ling L, Taur Y, Schluter J, Lubetzky M, Dadhania D, Pamer E, Suthanthiran M. Gut microbiota dysbiosis and diarrhea in kidney transplant recipients. Am J Transplant. 2019 Feb;19(2):488-500. doi: 10.1111/ajt.14974. Epub 2018 Jul 21. PMID 29920927
• Gabarre P, Loens C, Tamzali Y, Barrou B, Jaisser F, Tourret J. Immunosuppressive therapy after solid organ transplantation and the gut microbiota: Bidirectional interactions with clinical consequences. Am J Transplant. 2022 Apr;22(4):1014-1030. doi: 10.1111/ajt.16836. Epub 2021 Oct 15. PMID 34510717

Identifiers

NCT: NCT06708676 · WMT-SOT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗