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

BMC Gastroenterology

Research Article

Per G Farup¹  Solveig C Ligaarden¹  Lars Axelsson²  Kristine Naterstad²  Stian Lydersen³ 

[1] Department of Medicine, Innlandet Hospital Trust, Gjøvik, Norway;Unit for Applied Clinical Research, Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway;Nofima Mat AS, Ås, Norway;Unit for Applied Clinical Research, Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway;

关键词: Lactobacillus;    Irritable Bowel Syndrome;    Stool Frequency;    Stool Consistency;    Irritable Bowel Syndrome Symptom;   

DOI  :  10.1186/1471-230X-10-16

 received in 2009-04-20, accepted in 2010-02-10,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundSome 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.MethodsThe 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.ResultsThirteen 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.ConclusionsThis trial shows for the first time an unfavourable effect on symptoms in subjects with IBS after intake of a potential probiotic.The trial registration numberClinical trials NCT00355810.

【 授权许可】

CC BY   
© Ligaarden et al; licensee BioMed Central Ltd. 2010