title: Lactobacillus paracasei F19 versus placebo for the prevention of proton pump inhibitor-induced bowel symptoms: a randomized clinical trial.
abstract: BACKGROUND
  Proton pump inhibitors may foster intestinal dysbiosis and related bowel symptoms.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  Lactobacillus paracasei F19 supplementation prevents bowel symptom onset in patients on long-term proton pump inhibitors.
authors: Department of Clinical Medicine and Surgery, Gastroenterology Unit, University Federico II, Naples, Italy.
authors: Debora
authors: D
authors: Compare
authors: Department of Clinical Medicine and Surgery, Gastroenterology Unit, University Federico II, Naples, Italy.
authors: Alba
authors: A
authors: Rocco
authors: Department of Clinical Medicine and Surgery, Gastroenterology Unit, University Federico II, Naples, Italy.
authors: Costantino
authors: C
authors: Sgamato
authors: Department of Clinical Medicine and Surgery, Gastroenterology Unit, University Federico II, Naples, Italy.
authors: Pietro
authors: P
authors: Coccoli
authors: Gastroenterology Unit, Nuovo Regina Margherita Hospital, Rome, Italy.
authors: Salvatore Maria Antonio
authors: SM
authors: Campo
authors: Department of Health Science, University Magna Graecia, Catanzaro, Italy.
authors: Immacolata
authors: I
authors: Nazionale
authors: Department of Health Science, University Magna Graecia, Catanzaro, Italy.
authors: Tiziana
authors: T
authors: Larussa
authors: Department of Health Science, University Magna Graecia, Catanzaro, Italy.
authors: Francesco
authors: F
authors: Luzza
authors: Medical Statistics Unit, Second University of Naples, Complesso Didattico di S. Patrizia, Naples, Italy.
authors: Paolo
authors: P
authors: Chiodini
authors: Department of Clinical Medicine and Surgery, Gastroenterology Unit, University Federico II, Naples, Italy. Electronic address: nardone@unina.it.
authors: Gerardo
authors: G
authors: Nardone
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000009:adverse effects / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005764:Gastroesophageal Reflux / Q000188:drug therapy; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000139:chemically induced / Q000188:drug therapy*; D007778:Lactobacillus; D008297:Male; D008875:Middle Aged; D000077402:Pantoprazole; D019936:Probiotics / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; D000077402:Pantoprazole
keywords: Bloating; Flatulence; Lactobacillus paracasei subspecies Paracasei f19; Proton pump inhibitors