A 2-strain mixture of Lactobacillus acidophilus in the treatment of irritable bowel syndrome: A placebo-controlled randomized clinical trial

Dig Liver Dis. 2020 May;52(5):534-540. doi: 10.1016/j.dld.2019.12.009. Epub 2020 Jan 15.


Background: In the absence of a well-established therapeutic approach, patients with irritable bowel syndrome seek alternative strategies such as probiotics.

Aims: The current trial named LAPIBSS aimed to demonstrate the efficacy of a 2-strain mixture of Lactobacillus acidophilus to improve irritable bowel syndrome symptoms.

Methods: Eighty patients diagnosed for irritable bowel syndrome were recruited to a multicentre, double-blinded, in parallel groups, placebo-controlled, randomized clinical trial. Patients were provided with a daily dose of two capsules containing either probiotics (5 × 109 cfu/capsule) or placebo for 8 weeks. The primary outcome was abdominal pain score assessed with a 100-mm visual analogue scale. Secondary outcomes included scores of bloating, flatus and rumbling assessed with a 100-mm visual analogue scale, a composite score and bowel habits.

Results: Abdominal pain score was significantly improved in both groups at weeks 4 and 8 (P < 0.0001), but no significant differences were found between groups at week 8 (19.0 ± 2.5 vs 25.1 ± 2.6, respectively; LS Means differences = 6.0 ± 3.2; P = 0.06). Significant differences between groups were observed for flatus score at week 4 (P = 0.04) and week 8 (P = 0.03) and composite score (P = 0.04) at week 8.

Conclusions: The consumption of the 2-strain mixture of L. acidophilus over 8 weeks is safe and decreases significantly flatus and composite scores.

Trial registration number: EudraCT No 2008 A00844-51.

Keywords: Functional gastrointestinal disorders; Lactic acid bacteria; Microbiota; Probiotics.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdominal Pain / complications
  • Abdominal Pain / therapy*
  • Adult
  • Aged
  • Double-Blind Method
  • Female
  • Humans
  • Irritable Bowel Syndrome / complications
  • Irritable Bowel Syndrome / microbiology*
  • Irritable Bowel Syndrome / therapy*
  • Lactobacillus acidophilus / physiology*
  • Male
  • Middle Aged
  • Probiotics / adverse effects
  • Probiotics / therapeutic use*
  • Treatment Outcome

Associated data

  • EudraCT/2008 A00844-51