Probiotic Blend of Lactobacillus acidophilus LA-5 and Bifidobacterium animalis ssp. Lactis BB-12 in Non-constipated Irritable Bowel Syndrome: A Double-Blind Randomized Placebo-Controlled Trial.
- 2025-11-18
- Journal of gastroenterology and hepatology 41(1)
- Uday C Ghoshal
- B S Ramakrishna
- Pravin M Rathi
- Akash Shukla
- Manas Kumar Panigrahi
- Shubham Jain
- Indraneel Saha
- Karmabir Chakravartty
- Madhuri Singh
- Uzma Mustafa
- Shikha Sahu
- Ujjala Ghoshal
- Sanjay Chandnani
- Mahesh K Goenka
- Monjori Mitra
- PubMed: 41255078
- DOI: 10.1111/jgh.70137
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- Two hundred non-constipated IBS patients
- Methods
- Two hundred non-constipated IBS patients were randomized to the above-mentioned probiotic and placebo for 84 days
Background
As dysregulated gut microbiota is known in irritable bowel syndrome (IBS) and probiotics may improve it, we investigated the efficacy and safety of a combination probiotic, Lactobacillus acidophilus LA-5 and Bifidobacterium animalis ssp. lactis BB-12 in non-constipated IBS.Methods
Two hundred non-constipated IBS patients were randomized to the above-mentioned probiotic and placebo for 84 days. The outcome measures included IBS-Global Improvement Scale (IBS-GIS), IBS-Quality of Life (IBS-QoL), EAR3Q, IBS-Severity Scoring System (IBS-SSS), and patient-reported improvement. Fecal microbiota was evaluated in a subset.Results
Response in IBS-GIS was higher with probiotics than with placebo at days 28 (19.3% vs. 8.9%; p = 0.048), 56, and 84. Total and abdominal pain, distension, and QoL scores of IBS-SSS decreased at day 28 with probiotics that persisted till days 56 and 84. The percentage of patients with "severe" symptoms reduced from 20.8% at baseline to 3.9% at day 84, and the median IBS-QoL score decreased significantly at day 28; the beneficial effect on QoL was sustained till days 56 and 84 (p < 0.001). Improvement in abdominal pain, distension, urgency of defecation, bowel habit satisfaction, and stool frequency was noted earlier with probiotics than with placebo; 4.0% in the probiotic group and 0.9% in the placebo group had mild/moderate adverse events (p = 0.167). Symptom recurrence occurred in 3.0% in the probiotic group and 3.9% in the placebo group during follow-up of 180 days (p = 0.718). No difference was observed in the fecal microbiota between the two groups, but healthy genera were enriched with probiotics.Conclusions
The probiotic blend studied was more effective than placebo in non-constipated IBS in adults.Research Insights
Response in IBS-GIS was higher with probiotics than with placebo at days 28 (19.3% vs. 8.9%; p = 0.048), 56, and 84. Total and abdominal pain, distension, and QoL scores of IBS-SSS decreased at day 28 with probiotics that persisted till days 56 and 84.
- Effect
- Beneficial
- Effect size
- Moderate
the median IBS-QoL score decreased significantly at day 28; the beneficial effect on QoL was sustained till days 56 and 84 (p < 0.001).
- Effect
- Beneficial
- Effect size
- Moderate
No difference was observed in the fecal microbiota between the two groups, but healthy genera were enriched with probiotics.
- Effect
- Neutral
- Effect size
- Small
4.0% in the probiotic group and 0.9% in the placebo group had mild/moderate adverse events (p = 0.167).
- Effect
- Neutral
- Effect size
- Small
4.0% in the probiotic group and 0.9% in the placebo group had mild/moderate adverse events (p = 0.167).
- Effect
- Neutral
- Effect size
- Small
The percentage of patients with "severe" symptoms reduced from 20.8% at baseline to 3.9% at day 84
- Effect
- Beneficial
- Effect size
- Moderate