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Randomized Controlled Trial
. 2010 Feb 10:10:16.
doi: 10.1186/1471-230X-10-16.

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

Solveig C Ligaarden  1 , Lars Axelsson, Kristine Naterstad, Stian Lydersen, Per G Farup
Affiliations
Randomized Controlled Trial

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

Solveig C Ligaarden et al. BMC Gastroenterol. .

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 10(10) 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.

Trial registration: ClinicalTrials.gov NCT00355810.

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Figures

Figure 1
Figure 1
Flow chart of the participants through the trial.
Figure 2
Figure 2
IBS sum score during the trial by allocation group. The results are given as mean with SEM.
See this image and copyright information in PMC

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