Randomized clinical trial: Efficacy and safety of the live biotherapeutic product MRx1234 in patients with irritable bowel syndrome

Background: MRx1234 is a live biotherapeutic product that contains a strain of Blautia hydrogenotrophica. It is in development for the treatment of irritable bowel syndrome (IBS).
Aims: To assess the efficacy and safety of MRx1234 in patients with IBS with predominant constipation (IBS-C) or diarrhea (IBS-D).
Methods: The authors conducted a multicenter, randomized, double-blind, placebo-controlled, phase 2 trial. Patients aged 18–70 years in 2 parallel cohorts (IBS-C; IBS-D) were randomized (1:1) to MRx1234 or placebo for 8 weeks. The primary efficacy end point was overall responder rate – a composite of improved bowel habit (IBS-C: stool frequency; IBS-D: stool consistency) and abdominal pain intensity – for ≥ 50% of the treatment period in each cohort. Statistical testing was at a 1-sided 0.10 significance level.
Results: Of 366 randomized patients (164 IBS-C; 202 IBS-D), 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-C (25.0% vs. 17.1%) and IBS-D (23.4% vs. 17.8%) cohorts. Similar results were observed in the additional combined cohort analysis (24.1% vs. 17.5%; p = 0.063). For the components of the primary end point, significantly more patients on MRx1234 than placebo reported improvement in bowel habit in the IBS-C, IBS-D and combined cohorts, while improvements in abdominal pain were observed in each cohort. The safety profile of MRx1234 was similar to placebo.

Conclusions: MRx1234 has the potential to become a novel, safe treatment option for patients with irritable bowel syndrome with predominant constipation (IBS-C) or diarrhea (IBS-D), and for those who have mixed symptoms or transition between subtypes.

E.M.M. Quigley, M.D., Professor of Medicine, Division of Gastroenterology and Hepatology, Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist Hospital and Weill Cornell Medical College, Houston, TX, USA,
E-Mail: equigley@houstonmethodist.org

DOI: DOI: 10.1111/apt.17310

Back to overview

this could be of interest:

Colon to Rectum

Long-term gastrointestinal sequelae following COVID-19: A prospective follow-up cohort study

Clin Gastroenterol Hepatol. 2023;21(3):789–96.e1

Colon to Rectum

Post-COVID-19 irritable bowel syndrome

Gut. 2023;72(3):484–92

Marasco G, Cremon C, Barbaro MR, Cacciari G, Falangone F, Kagramanova A, Bordin D, Drug V, Miftode E, Fusaroli P, Mohamed SY, Ricci C, Bellini M, Rahman MM, Melcarne L, Santos J, Lobo B, Bor S, Yapali S, Akyol D, Sapmaz FP, Urun YY, Eskazan T, Celebi A, Kacmaz H, Ebik B, Binicier HC, Bugdayci MS, Yağcı MB, Pullukcu H, Kaya BY, Tureyen A, Hatemi İ, Koc ES, Sirin G, Calıskan AR, Bengi G, Alıs EE, Lukic S, Trajkovska M, Hod K, Dumitrascu D, Pietrangelo A, Corradini E, Simren M, Sjölund J, Tornkvist N, Ghoshal UC, Kolokolnikova O, Colecchia A, Serra J, Maconi G, De Giorgio R, Danese S, Portincasa P, Di Sabatino A, Maggio M, Philippou E, Lee YY, Salvi D, Venturi A, Borghi C, Zoli M, Gionchetti P, Viale P, Stanghellini V, Barbara G; GI-COVID19 study group

Go to article