{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T19:40:22Z","timestamp":1790797222495,"version":"4.1.0"},"reference-count":46,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2022,11,11]],"date-time":"2022-11-11T00:00:00Z","timestamp":1668124800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      MRx1234 is a live biotherapeutic product that contains a strain of\n                      <jats:italic>Blautia hydrogenotrophica.<\/jats:italic>\n                      It is in development for the treatment of irritable bowel syndrome (IBS).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To assess the efficacy and safety of MRx1234 in patients with IBS with predominant constipation (IBS\u2010C) or diarrhoea (IBS\u2010D)<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a multicentre, randomised, double\u2010blind, placebo\u2010controlled, phase 2 trial. Patients aged 18\u201370\u2009years in two parallel cohorts (IBS\u2010C; IBS\u2010D) were randomised (1:1) to MRx1234 or placebo for 8\u2009weeks. The primary efficacy endpoint was overall responder rate\u2014a composite of improved bowel habit (IBS\u2010C: stool frequency; IBS\u2010D: stool consistency) and abdominal pain intensity\u2014for \u226550% of the treatment period in each cohort. Statistical testing was at a one\u2010sided 0.10 significance level.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 366 randomised patients (164 IBS\u2010C; 202 IBS\u2010D), 365 received any study medication (177 MRx1234, 188 placebo). Numerically, although not statistically significantly different, more patients who received MRx1234 than placebo were overall responders in the IBS\u2010C (25.0% vs. 17.1%) and IBS\u2010D (23.4% vs. 17.8%) cohorts. Similar results were observed in the additional combined cohort analysis (24.1% vs. 17.5%;\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.063). For the components of the primary endpoint, significantly more patients on MRx1234 than placebo reported improvement in bowel habit in the IBS\u2010C, IBS\u2010D and combined cohorts, while improvements in abdominal pain were observed in each cohort. The safety profile of MRx1234 was similar to placebo.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>MRx1234 has the potential to become a novel, safe treatment option for patients with IBS\u2010C or IBS\u2010D, and for those who have mixed symptoms or transition between subtypes.<\/jats:p>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      #NCT03721107.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.17310","type":"journal-article","created":{"date-parts":[[2022,11,11]],"date-time":"2022-11-11T23:39:35Z","timestamp":1668209975000},"page":"81-93","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Randomised clinical trial: efficacy and safety of the live biotherapeutic product\n                    <scp>MRx1234<\/scp>\n                    in patients with irritable bowel syndrome"],"prefix":"10.1111","volume":"57","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4151-7180","authenticated-orcid":false,"given":"Eamonn M. M.","family":"Quigley","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Lynda K. and David M. Underwood Center for Digestive Disorders Houston Methodist Hospital and Weill Cornell Medical College  Houston Texas USA"},{"name":"Houston Methodist Gastroenterology Associates  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louise","family":"Markinson","sequence":"additional","affiliation":[{"name":"4D Pharma PLC  Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Stevenson","sequence":"additional","affiliation":[{"name":"4D Pharma PLC  Leeds UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F. Peter","family":"Treasure","sequence":"additional","affiliation":[{"name":"Peter Treasure Statistical Services  King's Lynn UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4121-7970","authenticated-orcid":false,"given":"Brian E.","family":"Lacy","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic  Jacksonville Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,11,11]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.02.031"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/SGA.0000000000000530"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41575-020-0286-8"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(20)30217-X"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2019.12.021"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.gtc.2021.04.001"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2007.04.005"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2016.09.049"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2012-302167"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v22.i7.2219"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v20.i10.2456"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-020-06109-5"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1080\/19490976.2016.1218585"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2021-324598"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001036"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2004.12.006"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2011.358"},{"key":"e_1_2_11_19_1","unstructured":"Food and Drug Administration (FDA).Early clinical trials with live biotherapeutic products: chemistry manufacturing and control information.2016[cited 2022 Jan 31]. 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