Clinical trial: Lactobacillus plantarum 299v (DSM 9843) improves symptoms of irritable bowel syndrome

Abstract

Aim: To assess the symptomatic efficacy of Lactobacillus plantarum 299v (L. plantarum 299v) (DSM 9843) for the relief of abdominal symptoms in a large subset of irritable bowel syndrome (IBS) patients fulfilling the Rome III criteria.

Methods: In this double blind, placebo-controlled, parallel-designed study, subjects were randomized to daily receive either one capsule of L. plantarum 299v (DSM 9843) or placebo for 4 wk. Frequency and intensity of abdominal pain, bloating and feeling of incomplete rectal emptying were assessed weekly on a visual analogue scale while stool frequency was calculated.

Results: Two hundred and fourteen IBS patients were recruited. After 4 wk, both pain severity (0.68 + 0.53 vs 0.92 + 0.57, P < 0.05) and daily frequency (1.01 + 0.77 vs 1.71 + 0.93, P < 0.05) were lower with L. plantarum 299v (DSM 9843) than with placebo. Similar results were obtained for bloating. At week 4, 78.1 % of the patients scored the L. plantarum 299v (DSM 9843) symptomatic effect as excellent or good vs only 8.1 % for placebo (P < 0.01).

Conclusion: A 4-wk treatment with L. plantarum 299v (DSM 9843) provided effective symptom relief, particularly of abdominal pain and bloating, in IBS patients fulfilling the Rome III criteria.

Keywords: Abdominal pain; Clinical trial; Irritable bowel syndrome; Lactobacillus plantarum 299v; Probiotics.

Figures

Figure 1

Flow-chart of the study. L. plantarum 299v: Lactobacillus plantarum 299v; FAS: Full analysis set; ITT: Intention to treat.

Figure 2

Changes in frequency and severity of symptoms in both groups. A: Abdominal pain; B: Bloating; C: Feeling of incomplete evacuation. L. plantarum (DSM 9843): Lactobacillus plantarum 299v. aP < 0.05 vs baseline group.

Figure 3

Changes in stool frequency in both groups. L. plantarum (DSM 9843): Lactobacillus plantarum 299v. aP < 0.05 vs baseline group.

Figure 4

Overall assessment of the treatment efficacy by the patients and by the investigators.