Publication:

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

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.