A double-blind placebo-controlled randomized trial on probiotics in small bowel bacterial overgrowth in children treated with omeprazole

J Pediatr (Rio J). 2013 Jul-Aug;89(4):381-7. doi: 10.1016/j.jped.2012.12.005. Epub 2013 Jun 21.


Objective: To evaluate the incidence of small bowel bacterial overgrowth (SBBO) in children treated with omeprazole, and to test whether probiotics influence the incidence.

Methods: A double-blinded, placebo-controlled trial was performed in 70 children treated orally during four weeks with 20mg omeprazole per day. Lactobacillus rhamnosus R0011 (1.9×10(9) cfu) and Lactobacillus acidophilus R0052 (0.1×10(9) cfu) were simultaneously given daily to 36 subjects (probiotic group), while 34 subjects received placebo (placebo group). The diagnosis of SBBO was based on the development of suggestive symptoms, in combination with a positive glucose breath test.

Results: After one month of proton pump inhibitor (PPI) treatment, 30% (21/70) had a positive breath test suggesting SBBO; of these 62% were symptomatic. Five children developed SBBO-like symptoms, but had a negative breath test; and 44 (63%) were symptom free and had a negative breath test. There was no difference in the incidence of positive breath tests in the probiotic versus the placebo group (33% vs 26.5%; p=0.13).

Conclusions: Since symptoms suggesting SBBO developed in 26% of PPI-treated children, and since the glucose breath test was abnormal in 72% of these, this side-effect should be more frequently considered. The probiotic tested did not decrease the risk to develop SBBO.

Keywords: (Hydrogen) breath test; Diarreia; Diarrhea; Flatulence; Flatulência; Inibidor da bomba de prótons; Omeprazol; Omeprazole; Probiotic; Probiótico; Proton pump inhibitor; Small bowel bacterial overgrowth; Supercrescimento bacteriano do intestino delgado; Teste de hidrogênio no ar expirado.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Bacterial Infections / drug therapy*
  • Bacterial Infections / microbiology
  • Bacterial Infections / prevention & control
  • Breath Tests
  • Child
  • Child, Preschool
  • Diarrhea / microbiology
  • Double-Blind Method
  • Female
  • Gastrointestinal Diseases / drug therapy
  • Gastrointestinal Diseases / microbiology*
  • Gastrointestinal Diseases / prevention & control
  • Humans
  • Intestine, Small / drug effects
  • Intestine, Small / microbiology*
  • Lacticaseibacillus rhamnosus
  • Lactobacillus acidophilus
  • Male
  • Omeprazole / administration & dosage
  • Omeprazole / adverse effects*
  • Placebos
  • Probiotics / therapeutic use*
  • Proton Pump Inhibitors / administration & dosage
  • Proton Pump Inhibitors / adverse effects*
  • Time Factors
  • Treatment Outcome


  • Placebos
  • Proton Pump Inhibitors
  • Omeprazole