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Scand J Gastroenterol. 2013 Oct;48(10):1127-35. doi: 10.3109/00365521.2013.825314. Epub 2013 Aug 19.

Long-term treatment with probiotics in primary care patients with irritable bowel syndrome--a randomised, double-blind, placebo controlled trial.

Author information

1
Research Unit of General Practice, Institute of Public Health, University of Southern Denmark , Odense , Denmark.

Abstract

OBJECTIVE:

Meta-analyses have indicated effect of probiotics on irritable bowel syndrome (IBS). However, few long-term trials have been conducted and uncertainty remains as to effectiveness and long-term effect in a primary care setting. We aimed to investigate the effect of probiotics compared with placebo in the management of IBS in primary care during a 6-month treatment period and with a 6-month follow-up.

MATERIAL AND METHODS:

We randomized IBS patients fulfilling Rome III criteria to receive two capsules twice daily either containing placebo or a probiotic mixture of Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12 in an amount of 1.3 × 10(10) CFU per capsule. Primary endpoint was proportion of responders defined as patients reporting adequate relief (AR) at least 50% of the time in the 6-month treatment period. Secondary outcomes were proportions of patients reporting AR at different time points, and change in gastrointestinal symptoms and health-related quality of life (HrQOL) from baseline to 6 and 12 months.

RESULTS:

A total of 131 patients were included in this study. The proportion of responders in the treatment period was 52% (35/67) in the probiotic group versus 41% (26/64) in the placebo group, p = 0.18. Overall we found no difference between the groups in change in gastrointestinal symptoms after treatment. Patients improved in HrQOL, but with no statistically significant difference between the groups.

CONCLUSION:

During a 6-month treatment period, we were not able to detect a positive effect of probiotic when compared with placebo.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01151657.

PMID:
23957590
DOI:
10.3109/00365521.2013.825314
[Indexed for MEDLINE]

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