BMC Gastroenterology

official impact factor 2.47
Search for
Advanced search
BMC Gastroenterology
Tools
Open Access Highly Access Research article

A candidate probiotic with unfavourable effects in subjects with irritable bowel syndrome: a randomised controlled trial

Solveig C Ligaarden1,2*, Lars Axelsson3, Kristine Naterstad3, Stian Lydersen2 and Per G Farup1,2

Author Affiliations

1 Department of Medicine, Innlandet Hospital Trust, Gjøvik, Norway

2 Unit for Applied Clinical Research, Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway

3 Nofima Mat AS, Ås, Norway

For all author emails, please log on.

BMC Gastroenterology 2010, 10:16 doi:10.1186/1471-230X-10-16

Published: 10 February 2010

Abstract

Background

Some probiotics have shown efficacy for patients with irritable bowel syndrome (IBS). Lactobacillus (L.) plantarum MF1298 was found to have the best in vitro probiotic properties of 22 strains of lactobacilli. The aim of this study was to investigate the symptomatic effect of L. plantarum MF1298 in subjects with IBS. Primary outcome was treatment preference and secondary outcomes were number of weeks with satisfactory relief of symptoms and IBS sum score.

Methods

The design was a randomised double blind placebo-controlled crossover trial. 16 subjects with IBS underwent two three-week periods of daily intake of one capsule of 1010 CFU L. plantarum MF 1298 or placebo separated by a four-week washout period.

Results

Thirteen participants (81%; 95% CI 57% to 93%; P = 0.012) preferred placebo to L. plantarum MF1298 treatment. The mean (SD) number of weeks with satisfactory relief of symptoms in the periods with L. plantarum MF1298 and placebo were 0.50 (0.89) and 1.44 (1.26), respectively (P = 0.006). IBS sum score was 6.44 (1.81) in the period with L. plantarum MF1298 treatment compared with 5.35 (1.77) in the period with placebo (P = 0.010). With a clinically significant difference in the IBS sum score of 2 in disfavour of active treatment, the number needed to harm was 3.7, 95% CI 2.3 to 10.9.

Conclusions

This trial shows for the first time an unfavourable effect on symptoms in subjects with IBS after intake of a potential probiotic.

The trial registration number

Clinical trials NCT00355810.