Irritable bowel syndrome (IBS) is one of the disorders most frequently diagnosed by gastroenterologists. Probiotics are promising tools for the management of IBS. The objective of the present study was to evaluate the effectiveness and tolerability of a probiotic (Bifidobacterium longum 35624®) in adults (aged 18 or over) with IBS (as defined by the Rome IV criteria). In an open-label, observational, post-market study conducted in Germany, adults with IBS and a prior recommendation for the intake of B. longum 35624® were recruited by family physicians. During the 8-week course of treatment, the study participants filled out a weekly questionnaire that enabled calculation of a total IBS symptom score (TISS, the sum of abdominal pain, bloating, passage of gas, constipation, and diarrhea individual symptom scores) and the well-known IBS severity scoring system (IBS-SSS) score. Thirty-seven patients were included. The course of B. longum 35624® was associated with a significant reduction (43.4%) in the TISS vs. baseline. The mean individual symptom grades for passage of gas and bloating fell significantly from "moderate" at baseline to "very mild to mild" after 8 weeks of treatment, whereas those for abdominal pain and diarrhea fell significantly from "mild to moderate" to "very mild to mild." Over 60% of the participants achieved clinically meaningful reductions in the TISS (> 30%) and the IBS-SSS score (> 50 points). The effectiveness of B. longum 35624® was rated as "good to satisfactory" by study participants and the investigating physicians. One mild adverse event (nausea) was potentially linked to the study treatment. We conclude that an 8-week course of B. longum 35624® was associated with significant, clinically meaningful symptom relief in a typical population of adult patients with IBS.
Keywords: Abdominal pain; Bifidobacterium longum 35624®; Irritable bowel syndrome; Post-market clinical follow-up study; Probiotics.
© 2023. The Author(s).