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Article Publish Status: FREE
Abstract Title:

Effect of35624 on disease severity and quality of life in patients with irritable bowel syndrome.

Abstract Source:

World J Gastroenterol. 2022 Feb 21 ;28(7):732-744. PMID: 35317278

Abstract Author(s):

Jean-Marc Sabaté, Franck Iglicki

Article Affiliation:

Jean-Marc Sabaté

Abstract:

BACKGROUND: 35624 has shown efficacy in improving irritable bowel syndrome (IBS) symptoms compared with placebo in double-blind randomized studies. However, few data are available from real-life clinical practice or from studies that used Rome IV criteria to diagnose IBS.

AIM: To assess the effect of35624 on IBS severity and quality of life in a real-life setting.

METHODS: From November 2018 to January 2020, 278 patients with IBS (according to Rome IV criteria) were enrolled in a prospective, open-label, multicenter observational study by private practice gastroenterologists to received one capsule of35624 (10colony-forming units)day for 30 d. Participation in the study was independently proposed to patients during spontaneous consultations. Disease severity (assessed by the IBS severity scoring system) and patient quality of life (assessed by the IBS quality of life questionnaire) were compared between the inclusion visit (baseline) and the visit at the end of 30 d of treatment. The characteristics of patients were described at baseline. Continuous variables comparisons between inclusion and end-of-treatment visits were performed using the t-test and Kruskal-Wallis test. Categorical variables comparisons were performed using theχ2 test.

RESULTS: A total of 233 patients, with a mean age of 51.4 years and composed of 71.2% women, were included in the study. Of these patients, 48.1% had moderate IBS and 46.4% had severe IBS. After a 30-d treatment period with one35624 capsuleday, a significant decrease in IBS severity was observed compared to baseline (mean± SD, IBS severity scoring system scores: 208 ± 104303± 81,<0.001) and 57% of patients moved to lower severity categories or achieved remission. The quality of life of patients was also improved by the treatment (IBS Quality of Life questionnaire score: 68.8± 20.960.2± 20.5;<0.001) and 63.8% of patients were satisfied with the treatment.

CONCLUSION: Thirty days of treatment with35624 reduces disease severity and improves the quality of life of patients with IBS, particularly those with the most severe forms of IBS.

Study Type : Human Study

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