Academic Journal
Safety comparison of single-donor and pooled fecal microbiota transfer product preparation in ulcerative colitis: systematic review and meta-analysis
| Title: | Safety comparison of single-donor and pooled fecal microbiota transfer product preparation in ulcerative colitis: systematic review and meta-analysis |
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| Authors: | Laperrousaz, Bastien, Levast, Benoît, Fontaine, Mathieu, Nancey, Stéphane, Dechelotte, Pierre, Dore, Joel, Lehert, Philippe |
| Contributors: | douville, sabine, MaaT Pharma Lyon, Service d'Hépatologie et de Gastroentérologie Lyon, Hospices Civils de Lyon (HCL), Autophagie infection et immunité - Autophagy Infection Immunity CIRI (CIRI-APY), Centre International de Recherche en Infectiologie (CIRI), École normale supérieure de Lyon (ENS de Lyon), Université de Lyon-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-École normale supérieure de Lyon (ENS de Lyon), Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Nutrition, Inflammation et axe Microbiote-Intestin-Cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Normandie Université (NU), Service de Nutrition CHU Rouen, CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), MetaGenoPolis (MGP (US 1367)), MICrobiologie de l'ALImentation au Service de la Santé (MICALIS), AgroParisTech-Université Paris-Saclay-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), UCL Crypto Group, Université Catholique de Louvain = Catholic University of Louvain (UCL), University of Melbourne |
| Source: | BMC Gastroenterol BMC Gastroenterology, Vol 24, Iss 1, Pp 1-12 (2024) |
| Publisher Information: | Springer Science and Business Media LLC, 2024. |
| Publication Year: | 2024 |
| Subject Terms: | Pooling, 0301 basic medicine, Benefit-risk, [SDV]Life Sciences [q-bio], Ulcerative, RC799-869, 03 medical and health sciences, MESH: Colitis, MESH: Fecal Microbiota Transplantation, Humans, MESH: Treatment Outcome, Randomized Controlled Trials as Topic, 0303 health sciences, MESH: Humans, Fecal microbiota transfer, Research, Diseases of the digestive system. Gastroenterology, Fecal Microbiota Transplantation, [SDV] Life Sciences [q-bio], Meta-analysis, MESH: Randomized Controlled Trials as Topic, Treatment Outcome, Ulcerative colitis, Colitis, Ulcerative, Safety |
| Description: | Multiple studies have evaluated fecal microbiota transfer (FMT) in patients with ulcerative colitis (UC) using single-donor (SDN) and multidonor (MDN) products. Systematic review and meta-analysis were performed to compare the safety of SDN and MDN products.Systematic searches were performed in Web of Science, Scopus, PubMed, and Orbit Intelligence to identify studies that compared FMT products manufactured using SDN or MDN strategies against control treatment in patients with UC. Fifteen controlled studies were selected for meta-analysis (11 randomized controlled trials and 4 controlled cohort trials). Safety of each treatment type was assessed using the counts of adverse events and serious adverse events using fixed- and random-effects models. Significance of the indirect difference between FMT preparations was assessed using a network approach. Benefit-risk ratios were calculated by multiplicative utility model, incorporating geometric mean of risk ratios (RRs) of efficacy and safety.Safety data was collected for a total of 587 patients (193 exposed to SDN products, 114 exposed to MDN products and 280 exposed to control treatment). The 12 studies showed similar overall safety event counts for MDN and SDN versus placebo (RRs: 0.90 and 1.09, respectively [P = 0.206 and P = 0.420, respectively]). Results indicated similar risk of safety events for MDN compared to SDN (RR: 0.83, P = 0.159). Positive benefit-risk ratios were demonstrated for MDN and SDN versus placebo (RRs: 1.70 and 1.16, respectively [P = 0.003 and P = 0.173, respectively]). MDN had a greater benefit-risk ratio compared to SDN (RR: 1.46, P = 0.072).Similar safety profiles were observed for MDN and SDN strategies. Alongside previously described superior efficacy, treatment with MDN has greater benefit-risk ratio than SDN in patients with UC. Further development of MDN FMT treatment for UC should be considered. |
| Document Type: | Article Other literature type |
| Language: | English |
| ISSN: | 1471-230X |
| DOI: | 10.1186/s12876-024-03487-2 |
| Access URL: | https://pubmed.ncbi.nlm.nih.gov/39528920 https://doaj.org/article/76d1f1b1578f47ebb1b17441928000b7 |
| Rights: | CC BY NC ND |
| Accession Number: | edsair.doi.dedup.....fc7a379da2438aae3e9f07b18c28ff9a |
| Database: | OpenAIRE |
| ISSN: | 1471230X |
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| DOI: | 10.1186/s12876-024-03487-2 |