Elsevier

Clinical Nutrition

Volume 24, Issue 6, December 2005, Pages 925-931
Clinical Nutrition

ORIGINAL ARTICLE
The efficacy of Lactobacillus reuteri ATCC 55730 in the treatment of patients with irritable bowel syndrome—a double blind, placebo-controlled, randomized study

https://doi.org/10.1016/j.clnu.2005.06.001Get rights and content

Summary

Background

It was suggested that the intestinal microflora may play a role in the pathogenesis of irritable bowel syndrome (IBS). Probiotics may ease symptoms in IBS patients by changing gut microflora, reducing mucosal inflammation and exerting antibacterial effects.

Aim

To assess the short- and long-term effects of Lactobacillus reuteri administration on clinical symptoms of IBS.

Methods

This is a double blind, placebo-controlled 6-month trial. Subjects consumed 1×108 cfu/tablet twice a day. The clinical severity of the IBS symptoms was evaluated by the Francis Severity score and the IBS quality-of-life score at study entry and then monthly.

Results

In total, 54 subjects were randomized for treatment and 39 concluded the study. Both groups (treatment and placebo) improved significantly in all the studied parameters with no significant differences between groups. Two parameters, constipation and passing gasses, were marginally different between the main groups (P=0.0714 and 0.0971, respectively).

Conclusions

IBS symptoms did not improve with probiotic treatment with L. reuteri. A strong placebo effect and a lack of uniformity of the IBS population may have hindered a clearer demonstration of the effect.

Introduction

Irritable bowel syndrome (IBS) is a benign, relapsing chronic disorder characterized by recurrent abdominal pain and altered bowel function. It is estimated that 9–22% of the general population suffer from the clinical symptoms of IBS, but only 5% seek medical advice.1, 2, 3, 4 IBS contributes considerably to disability, absence from work or school and increased health-care costs.

Treatment of IBS is very problematic. Despite the wide range of pharmacological and non-pharmacological therapies, there is no universally accepted approach.5 Probiotics improved different gastrointestinal (GI) disorders such as infectious diarrhea in children, recurrent Clostridium difficile-induced diarrhea and post-operative pouchitis.6 Probiotics were also considered as a possible therapy for IBS, by changing intestinal microflora of the GI tract7, 8 or perhaps through the production of antimicrobial metabolites or by modulation of the local immune response to enteric bacteria.9 The positive effect of probiotics on IBS symptoms has recently been reported in a number of studies,10, 11, 12 but most of them included a small number of patients, were not randomized placebo-controlled investigations, and lasted for only 4–6 weeks, thereby not taking into account the fluctuating nature of IBS.

Lactobacillus reuteri (L. reuteri) is a major component of the lactobacillus populations which naturally inhabit the GI tract of humans and animals.13 L. reuteri is known to produce a broad-spectrum antimicrobial substance, reuterin (3-hydroxy-propionaldehyde), during anaerobic growth in the presence of glycerol.14 Being a heterofermentative lactobacterium, L. reuteri decreases the intestinal pH to a level that is unfavorable to most pathogenic bacteria and so the antimicrobial effect is enhanced. Consistent with this, L. reuteri has been shown in vitro to strongly inhibit a number of pathogenic bacteria while having no inhibitory influence on other Lactobacillus species and other bacteria normally residing in the GI tract.15, 16 The role of L. reuteri in the treatment of IBS has never been investigated.

The aim of this study was to assess the short- and long-term effects of L. reuteri on the clinical symptoms of IBS.

Section snippets

Subjects

The current study was performed as a prospective, double blind, placebo-controlled trial. Patients were recruited from the outpatient clinics of the Departments of Gastroenterology of the Sourasky and the Sapir Medical Centers. They were screened by one of the investigators (EN) and recruited according to the study inclusion criteria and their willingness to participate. All types of IBS were included into the study: constipation-predominant, diarrhea-predominant and mixed types. All patients

Results

One-hundred and ten patients underwent screening for the study of whom 54 fulfilled the inclusion criteria and passed the run-in period and were randomized equally into two groups. The rest of the patients were excluded because of various reasons: 30 patients declined, 6 withdrew their consent during the run-in period, 10 did not fulfill the Rome II criteria, 9 were older than 70 years of age, and one discovered that she was pregnant (Fig. 1).

Table 1 presents the demographic data of the 54

Discussion

The findings of our study indicate that the administration of L. reuteri ATCC 55730 did not improve any of the symptoms in a mixed group of patients with IBS. Non-significant statistical differences between the groups, indicating a possible improvement (lowered frequency) were found for passing of gases and constipation, two of the main complaints of IBS. The lack of any prominence in the differences between the study group and the placebo group reflects the improvement of symptoms in the

Acknowledgment

Esther Eshkol is thanked for editorial assistance. The study was supported by BioGais, Stockholm, Sweden.

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