Lactobacillus paracasei F19 versus placebo for the prevention of proton pump inhibitor-induced bowel symptoms: a randomized clinical trial

Dig Liver Dis. 2015 Apr;47(4):273-9. doi: 10.1016/j.dld.2015.01.004. Epub 2015 Jan 19.

Abstract

Background: Proton pump inhibitors may foster intestinal dysbiosis and related bowel symptoms.

Aim: To evaluate the effect of Lactobacillus paracasei F19 on bowel symptom onset in patients on long-term proton pump inhibitors.

Methods: In this randomized, double-blind, placebo-controlled study, patients with typical gastroesophageal reflux disease symptoms receiving pantoprazole 40 mg/d for six months were randomly assigned to receive: (A) Lactobacillus paracasei F19 bid for three days/week for six months; (B) placebo bid for three days/week for six months; (C) Lactobacillus paracasei F19 bid for three days/week for three months and placebo bid for three days/week for the following three months; (D) placebo bid for three days/week for three months and Lactobacillus paracasei F19 bid for three days/week for the following three months. Bloating, flatulence, abdominal pain and bowel habit were assessed monthly.

Results: 100/312 patients were enrolled. In the parallel groups, the treatment-by-time interaction affected bloating (p = 0.015), while Lactobacillus paracasei F19 treatment alone affected flatulence (p = 0.011). Moreover, the treatment-by-time interaction significantly affected the mean score of bloating (p = 0.01) and flatulence (p < 0.0001), the mean stool form (p = 0.03) and mean stool frequency/week (p = 0.016). Analysis of the cross-over groups, limited to the first three months because of carry-over effect, confirmed these results.

Conclusion: Lactobacillus paracasei F19 supplementation prevents bowel symptom onset in patients on long-term proton pump inhibitors.

Keywords: Bloating; Flatulence; Lactobacillus paracasei subspecies Paracasei f19; Proton pump inhibitors.

Publication types

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

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles / adverse effects
  • 2-Pyridinylmethylsulfinylbenzimidazoles / therapeutic use
  • Adolescent
  • Adult
  • Aged
  • Cross-Over Studies
  • Dietary Supplements*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Gastroesophageal Reflux / drug therapy
  • Humans
  • Irritable Bowel Syndrome / chemically induced
  • Irritable Bowel Syndrome / drug therapy*
  • Lactobacillus*
  • Male
  • Middle Aged
  • Pantoprazole
  • Probiotics / therapeutic use*
  • Proton Pump Inhibitors / adverse effects*
  • Proton Pump Inhibitors / therapeutic use
  • Treatment Outcome
  • Young Adult

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Proton Pump Inhibitors
  • Pantoprazole