Observational study to assess efficacy and safety of Bifidobacterium longum W11 + fructo-oligosaccharide combination in patients with irritable bowel syndrome

Ramesh Garg

doi:10.18203/2320-6012.ijrms20263504

Authors

Ramesh Garg Department of Gastroenterology, Liver Gastro Clinic, Shalimar Bagh, New Delhi, India

DOI:

https://doi.org/10.18203/2320-6012.ijrms20263504

Keywords:

Bifidobacterium longum W11, Fructo-oligosaccharide, IBS-SSS, Irritable bowel syndrome

Abstract

Background: Irritable bowel syndrome (IBS) is a prevalent functional gastrointestinal disorder. Synbiotics, combinations of probiotics and prebiotics offer a promising therapeutic approach, particularly formulations involving Bifidobacterium longum W11 and fructo-oligosaccharides (FOS). To assess the improvement in global IBS symptoms compared to baseline.

Methods: A prospective, single-arm, open-label observational study was conducted involving 50 patients with IBS (predominantly IBS-D and IBS-M subtypes). Participants received a daily oral dose of Bifidobacterium longum W11 (5 billion CFU) and FOS (2.5 gm) for 30 days. Clinical outcomes were assessed using the irritable bowel syndrome symptom severity scale (IBS-SSS), and patient-reported stool frequency and consistency verbal feedback. Evaluations were performed at baseline, day 15, and day 30. Continuous variables are summarized using N, mean, SD, median, minimum, and maximum/range. Categorical variables were presented as number of patients and N (%) based on exposed participants.

Results: The study showed significant symptom relief; IBS-SSS scores dropped 75.6% (362.6 to 90.4, p<0.001) by day 30, with major improvements in abdominal pain (−93-94%), distension (−74%), bowel habit dissatisfaction (−65%), and QoL interference (−63%). Severity shifted from predominantly severe to mild/normal. Stool normalized in all patients, frequency reduced from 5 to 2 per day (p<0.001), and no adverse events occurred.

Conclusions: The synbiotic combination of Bifidobacterium longum W11 and FOS demonstrated significant clinical benefits by helping to reduce IBS symptoms, normalizing stool patterns, and improving quality of life over a 30-day period.

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