Research Study

A randomised, double-blind, placebo-controlled trial:
the effects of a multi-strain probiotic, in adults with diarrhoea-predominant IBS

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A randomised, double-blind, placebo-controlled trial: the effects of a multi-strain probiotic, in adults with diarrhoea-predominant IBS

Question
Is a multi-strain probiotic more effective than placebo at reducing GI symptoms and improving QoL in patients with IBS-D?

Methods

360 out of 400 participants diagnosed with moderate-to-severe symptomatic diarrhoea-predominant IBS (IBS-D), in accordance with Rome III criteria, completed a trial to receive probiotic (14 bacteria strains; 8 billion CFU per day) or placebo capsules for 16 weeks. IBS symptoms (e.g abdominal pain and frequency, measured by the IBS-SSS questionnaire) and quality of life (measured by the 34-item IBS-QoL questionnaire) were assessed monthly for 5 months. No change in lifestyle/diet was introduced.

Results

181 patients received probiotic and 179 received placebo. At month 5, abdominal pain level had decreased significantly more in the probiotic group than in the placebo group (58.5 ± 11.1 to 18.1 ± 15.2 vs. 57.2 ± 10.6 to 30.2 ± 19.9; p<0.001).

The number of bowel motions/day was significantly reduced from month 2 onwards in the probiotic group, compared with the placebo group.

At baseline, all patients rated their symptoms as moderate to severe while at the end of the trial, this was reduced to 13.8% in the probiotic group compared with 48.0% in the placebo group (p<0.001). No serious adverse events were reported.

Conclusion

The multi-strain probiotic was associated with a statistically significant consistent improvement in overall symptom severity in patients with IBS-D, and was well tolerated.

Key findings

1. Abdominal pain level had decreased by almost 70% in the intervention group vs 47% in the placebo at follow-up;
2. IBS pain frequency decreased by >70% (7.7 per 10 days to 2.2 at month 5)
3. All dimensions of QoL showed significantly greater and consistent improvement in the intervention group than in the placebo group;
4. At the end of the trial 34% of patients in the intervention group vs 13% in placebo group were symptom-free

Ishaque SM, Khosruzzaman SM, Ahmed DS, Sah MP. A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult®) in the management of diarrhea-predominant irritable bowel syndrome. BMC Gastroenterol 2018;18(1):71.

Probiotic Supplement used = Bio-Kult Advanced (Ingredients - Bulking agent: microcrystalline cellulose, Bacillus subtilis PXN® 21™, Bifidobacterium bifidum PXN® 23™, Bifidobacterium breve PXN® 25™, Bifidobacterium infantis PXN® 27™, Bifidobacterium longum PXN® 30™, Lactobacillus acidophilus PXN® 35™, Lactobacillus delbrueckii ssp. bulgaricus PXN® 39™, Lactobacillus casei PXN® 37™, Lactobacillus plantarum PXN® 47™, Lactobacillus rhamnosus PXN® 54™, Lactobacillus helveticus PXN® 45™, Lactobacillus salivarius PXN® 57™, Lactococcus lactis ssp. lactis PXN® 63™, Streptococcus thermophilus PXN® 66™, (milk, soya), vegetable capsule (hydroxypropyl methylcellulose).)