ORIGINAL ARTICLEThe efficacy of Lactobacillus reuteri ATCC 55730 in the treatment of patients with irritable bowel syndrome—a double blind, placebo-controlled, randomized study
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.
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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.
References (25)
Diagnosis of irritable bowel syndrome
Gastroenterology
(2002)- et al.
Alteration of intestinal microflara is associated with reduction in abdominal bloating and pain in patients with irritable bowel syndrome
Am J Gastroenterol
(2000) - et al.
Effects of probiotic administration upon the composition and enzymatic activity of human fecal microbiota in patients with irritable bowel syndrome or functional diarrhea
Res Microbiol
(2001) - et al.
Bacterial supplementation in the irritable bowel syndrome. A randomized double-blind placebo-controlled crossover study
Dig Liver Dis
(2000) - et al.
Lactobacillus and Bifidobacterium in Irritable Bowel Syndrome: symptom responses and relationship to cytokine profiles
Gastroenterology
(2005) - Jones J, Boorman J, Cann P, et al. British Society of Gastroenterology guidelines for the management of the irritable...
Irritable bowel syndrome
Nurse Pract
(1998)- et al.
Irritable bowel syndrome
Semin Gastrointest Dis
(1996) Irritable bowel syndrome
N Engl J Med
(2003)- et al.
Probiotics and prebiotics in gastrointestinal disorders
Curr Opin Gastroenterol
(2004)
A review of the role of the gut microflora in irritable bowel syndrome and the effects of probiotics
Br J Nutr
Probiotics and gastrointestinal health
Gastroenterology
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