Elsevier

Nutrition

Volume 30, Issue 10, October 2014, Pages 1151-1157
Nutrition

Applied nutritional investigation
Randomized clinical trial: Effect of Lactobacillus plantarum 299 v on symptoms of irritable bowel syndrome

https://doi.org/10.1016/j.nut.2014.02.010Get rights and content

Abstract

Objectives

Irritable bowel syndrome (IBS) is a common diagnosis in gastroenterology. Its etiology is unknown and therapeutic options limited. Trials suggest probiotics may be beneficial. The aim of this study was to assess the symptomatic efficacy of Lactobacillus plantarum 299 v (L. plantarum 299 v) for the relief of abdominal pain in patients with IBS fulfilling Rome II criteria.

Methods

This study was conducted in a referral hospital. Trial participants were randomized to receive either two capsules of L. plantarum 299 v at a dosage of 5 × 109 cfu per capsule or placebo daily for 8 wk. Severity of abdominal pain was assessed using a visual analog scale at each visit and a quality-of-life IBS (QoL-IBS) questionnaire was also completed.

Results

There was no significant difference in abdominal pain relief between the study and placebo groups (P = 0.800). There was also no difference in QoL- IBS scores between the groups (P = 0.687). Both groups had a significant improvement in abdominal pain scores over the study period, from an average of 251.55 to 197.90 (P < 0.0001) indicating a large placebo effect.

Conclusion

An 8-wk treatment with L. plantarum 299 v did not provide symptomatic relief, particularly of abdominal pain and bloating, in patients fulfilling the Rome II criteria.

Section snippets

Background

Multiple clinical trials within the past decade have aimed to study the safety and efficacy of various probiotic strains in treating patients with irritable bowel syndrome (IBS). These trials provide guidance to health care professionals as they strive to treat patients suffering with IBS. Both positive and negative trial results provide a way forward and assist in the decision-making process. Health care workers are assailed with advertisements, representative details, patient expectations,

Participants

The present study was performed as a double-blind, placebo-controlled trial. Patients were recruited at a private gastroenterology clinic in Port Elizabeth, South Africa between January 2011 and April 2013. They were screened and recruited according to the study inclusion criteria and their willingness to participate. Constipation-predominant IBS (C-IBS) and diarrhea-predominant IBS (D-IBS) were included; the mixed type of IBS was excluded. Only C-IBS, D-IBS, and a placebo group were included

Results

The flow chart of the study is given in Figure 1. Eighty-one patients met the inclusion criteria, passed the run-in period, and were randomized. Fifty-four (66%) patients were randomized to receive L. plantarum 299 v and 27 (33%) the placebo; ratio of 2:1. Of the 54 patients randomized to receive the L. plantarum 299 v (50%, n = 27, were C-IBS and the other half, n = 27, D-IBS), the placebo was also equally distributed among D-IBS and C-IBS participants. The results are presented as the study

Discussion

The aim of this study was to conduct an appropriately well-designed randomized, double-blind, placebo-controlled clinical trial with L. plantarum 299 v and to determine its efficacy in IBS. No significant beneficial effects by the probiotic were seen on the severity of symptoms (abdominal pain) and quality of life.

To our knowledge this is the longest RCT reporting the effects of L. plantarum 299 v. Earlier interventions with L. plantarum 299 v had a 4-wk treatment phase [6], [7], [8], [28].

Conclusion

This study has demonstrated that an 8-wk treatment with L. plantarum 299 v did not provide relief for patients with moderate IBS symptoms over placebo and a very large placebo effect was demonstrated.

It is of the utmost importance that researchers strive to assess the efficacy of probiotics over placebo in treating patients with IBS and this means using more objective assessment methods. Probiotics may also prove to be a better treatment option in patients whose symptoms are on the lower end of

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    This study was funded in part by Nestle Nutrition Institute Africa and the South African National Research Foundation, gun number 2075266. CS, RB, EF, JV, and SR designed the research. CS and EF performed the research. CS analyzed the data. All authors helped draft the article. The authors declare they have no competing interests.

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