CMTS0929 for Inflammatory Bowel Disease

Summary

This is a prospective, open-label, single-arm study to explore the safety and the efficacy of China Microbiota Transplantation System 0929 (CMTS0929) for patients with inflammatory bowel disease (IBD).

Timeline

Start

2025-02-20

Primary completion

2030-01-31

Completion

2030-07-01

Publications

• Background Wortelboer K, de Jonge PA, Scheithauer TPM, Attaye I, Kemper EM, Nieuwdorp M, Herrema H. Phage-microbe dynamics after sterile faecal filtrate transplantation in individuals with metabolic syndrome: a double-blind, randomised, placebo-controlled clinical trial assessing efficacy and safety. Nat Commun. 2023 Sep 12;14(1):5600. doi: 10.1038/s41467-023-41329-z.
• Background Shaukat A, Shyne M, Mandel JS, Snover D, Church TR. Colonoscopy With Polypectomy Reduces Long-Term Incidence of Colorectal Cancer in Both Men and Women: Extended Results From the Minnesota Colon Cancer Control Study. Gastroenterology. 2021 Mar;160(4):1397-1399.e3. doi: 10.1053/j.gastro.2020.11.014. Epub 2020 Nov 17. No abstract available.
• Background Zhang F, Cui B, He X, Nie Y, Wu K, Fan D; FMT-standardization Study Group. Microbiota transplantation: concept, methodology and strategy for its modernization. Protein Cell. 2018 May;9(5):462-473. doi: 10.1007/s13238-018-0541-8. Epub 2018 Apr 24.
• Background Piovani D, Hassan C, Repici A, Rimassa L, Carlo-Stella C, Nikolopoulos GK, Riboli E, Bonovas S. Risk of Cancer in Inflammatory Bowel Diseases: Umbrella Review and Reanalysis of Meta-analyses. Gastroenterology. 2022 Sep;163(3):671-684. doi: 10.1053/j.gastro.2022.05.038. Epub 2022 May 26.
• Background Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1.
• Background Hodson R. Inflammatory bowel disease. Nature. 2016 Dec 21;540(7634):S97. doi: 10.1038/540S97a. No abstract available.

Drugs

Indications