Biomaterial Database

Fecal microbiota transplantation to maintain remission in Crohn's disease: a pilot randomized controlled study. 2020

Harry Sokol, and Cecilia Landman, and Philippe Seksik, and Laurence Berard, and Mélissa Montil, and Isabelle Nion-Larmurier, and Anne Bourrier, and Guillaume Le Gall, and Valérie Lalande, and Alexis De Rougemont, and Julien Kirchgesner, and Anne Daguenel, and Marine Cachanado, and Alexandra Rousseau, and Élodie Drouet, and Michelle Rosenzwajg, and Hervé Hagege, and Xavier Dray, and David Klatzman, and Philippe Marteau, and , and Laurent Beaugerie, and Tabassome Simon

Centre de Recherche Saint-Antoine, CRSA, AP-HP, Hôpital Saint Antoine, Service de Gastroenterologie, Sorbonne Université, Inserm, 75012, Paris, France. harry.sokol@aphp.fr.

The role of the gut microbiota in Crohn's disease (CD) is established and fecal microbiota transplantation (FMT) is an attractive therapeutic strategy. No randomized controlled clinical trial results are available. We performed a randomized, single-blind, sham-controlled pilot trial of FMT in adults with colonic or ileo-colonic CD. Patients enrolled while in flare received oral corticosteroid. Once in clinical remission, patients were randomized to receive either FMT or sham transplantation during a colonoscopy. Corticosteroids were tapered and a second colonoscopy was performed at week 6. The primary endpoint was the implantation of the donor microbiota at week 6 (Sorensen index > 0.6). Eight patients received FMT and nine sham transplantation. None of the patients reached the primary endpoint. The steroid-free clinical remission rate at 10 and 24 weeks was 44.4% (4/9) and 33.3% (3/9) in the sham transplantation group and 87.5% (7/8) and 50.0% (4/8; one patient loss of follow-up while in remission at week 12 and considered in flare at week 24) in the FMT group. Crohn's Disease Endoscopic Index of Severity decreased 6 weeks after FMT (p = 0.03) but not after sham transplantation (p = 0.8). Conversely, the CRP level increased 6 weeks after sham transplantation (p = 0.008) but not after FMT (p = 0.5). Absence of donor microbiota engraftment was associated with flare. No safety signal was identified. The primary endpoint was not reached for any patient. In this pilot study, higher colonization by donor microbiota was associated with maintenance of remission. These results must be confirmed in larger studies (NCT02097797). Video abstract.

UI	MeSH Term	Description	Entries
D008297	Male		Males
D010865	Pilot Projects	Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work.	Pilot Studies,Pilot Study,Pilot Project,Project, Pilot,Projects, Pilot,Studies, Pilot,Study, Pilot
D012074	Remission Induction	Therapeutic act or process that initiates a response to a complete or partial remission level.	Induction of Remission,Induction, Remission,Inductions, Remission,Remission Inductions
D012107	Research Design	A plan for collecting and utilizing data so that desired information can be obtained with sufficient precision or so that an hypothesis can be tested properly.	Experimental Design,Data Adjustment,Data Reporting,Design, Experimental,Designs, Experimental,Error Sources,Experimental Designs,Matched Groups,Methodology, Research,Problem Formulation,Research Methodology,Research Proposal,Research Strategy,Research Technics,Research Techniques,Scoring Methods,Adjustment, Data,Adjustments, Data,Data Adjustments,Design, Research,Designs, Research,Error Source,Formulation, Problem,Formulations, Problem,Group, Matched,Groups, Matched,Matched Group,Method, Scoring,Methods, Scoring,Problem Formulations,Proposal, Research,Proposals, Research,Reporting, Data,Research Designs,Research Proposals,Research Strategies,Research Technic,Research Technique,Scoring Method,Source, Error,Sources, Error,Strategies, Research,Strategy, Research,Technic, Research,Technics, Research,Technique, Research,Techniques, Research
D003424	Crohn Disease	A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.	Colitis, Granulomatous,Enteritis, Granulomatous,Enteritis, Regional,Ileitis, Regional,Ileitis, Terminal,Ileocolitis,Crohn's Disease,Crohn's Enteritis,Inflammatory Bowel Disease 1,Regional Enteritis,Crohns Disease,Granulomatous Colitis,Granulomatous Enteritis,Regional Ileitides,Regional Ileitis,Terminal Ileitis
D005243	Feces	Excrement from the INTESTINES, containing unabsorbed solids, waste products, secretions, and BACTERIA of the DIGESTIVE SYSTEM.
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069467	Fecal Microbiota Transplantation	Transfer of GASTROINTESTINAL MICROBIOTA from one individual to another by infusion of donor FECES to the upper or lower GASTROINTESTINAL TRACT of the recipient.	Fecal Microbiome Transplantation,Fecal Microbiota Transfer,Fecal Microbiota Transplant,Intestinal Microbiome Transfer,Intestinal Microbiome Transplant,Intestinal Microbiome Transplantation,Intestinal Microbiota Transplant,Intestinal Microbiota Transplantation,Donor Feces Infusion,Fecal Transplant,Fecal Transplantation,Intestinal Microbiota Transfer,Donor Feces Infusions,Fecal Microbiome Transplantations,Fecal Microbiota Transfers,Fecal Microbiota Transplantations,Fecal Microbiota Transplants,Fecal Transplantations,Fecal Transplants,Feces Infusion, Donor,Feces Infusions, Donor,Infusion, Donor Feces,Infusions, Donor Feces,Intestinal Microbiome Transfers,Intestinal Microbiome Transplantations,Intestinal Microbiome Transplants,Intestinal Microbiota Transfers,Intestinal Microbiota Transplantations,Intestinal Microbiota Transplants,Microbiome Transfer, Intestinal,Microbiome Transfers, Intestinal,Microbiome Transplant, Intestinal,Microbiome Transplantation, Fecal,Microbiome Transplantation, Intestinal,Microbiome Transplantations, Fecal,Microbiome Transplantations, Intestinal,Microbiome Transplants, Intestinal,Microbiota Transfer, Fecal,Microbiota Transfer, Intestinal,Microbiota Transfers, Fecal,Microbiota Transfers, Intestinal,Microbiota Transplant, Fecal,Microbiota Transplant, Intestinal,Microbiota Transplantation, Fecal,Microbiota Transplantation, Intestinal,Microbiota Transplantations, Fecal,Microbiota Transplantations, Intestinal,Microbiota Transplants, Fecal,Microbiota Transplants, Intestinal,Transfer, Fecal Microbiota,Transfer, Intestinal Microbiome,Transfer, Intestinal Microbiota,Transfers, Fecal Microbiota,Transfers, Intestinal Microbiome,Transfers, Intestinal Microbiota,Transplant, Fecal,Transplant, Fecal Microbiota,Transplant, Intestinal Microbiome,Transplant, Intestinal Microbiota,Transplantation, Fecal,Transplantation, Fecal Microbiome,Transplantation, Fecal Microbiota,Transplantation, Intestinal Microbiome,Transplantation, Intestinal Microbiota,Transplantations, Fecal,Transplantations, Fecal Microbiome,Transplantations, Fecal Microbiota,Transplantations, Intestinal Microbiome,Transplantations, Intestinal Microbiota,Transplants, Fecal,Transplants, Fecal Microbiota,Transplants, Intestinal Microbiome,Transplants, Intestinal Microbiota
D000305	Adrenal Cortex Hormones	HORMONES produced by the ADRENAL CORTEX, including both steroid and peptide hormones. The major hormones produced are HYDROCORTISONE and ALDOSTERONE.	Adrenal Cortex Hormone,Corticoid,Corticoids,Corticosteroid,Corticosteroids,Cortex Hormone, Adrenal,Hormone, Adrenal Cortex,Hormones, Adrenal Cortex