Lactobacillus Reuteri Strain Combination (Strains DSM 17938 and ATCC PTA 6475) in Children Treated With Proton Pump Inhibitors

What this Trial Is About

Researchers are studying the effects of a probiotic called Gastrus, which contains two strains of Lactobacillus reuteri, in children taking proton pump inhibitors (PPIs) for gastric conditions like gastroesophageal reflux disease or functional dyspepsia. The study aims to see if Gastrus can reduce the occurrence of small intestinal bacterial overgrowth (SIBO), lower infection risks, and prevent imbalances in gut bacteria in these children. Gastrus combines one strain known for its use in gastric infections and another with anti-inflammatory properties and acid resistance. Participants receive either Gastrus or a placebo in the form of sachets or chewable capsules, both identical in appearance and taste. They take two sachets or capsules twice daily during the entire PPI treatment period of eight weeks, plus two additional weeks after stopping PPI use. A final assessment is conducted four weeks after stopping both Gastrus and placebo. Compliance is monitored using alarm devices, and participants who consume at least 80% of doses are included in the per-protocol analysis. Children taking part in the study will have breath tests and health questionnaires at the start and at week 10 to assess bacterial overgrowth and health status. Additional stool sample analysis and gastrointestinal symptom ratings occur at week 14. The researchers will monitor adherence and collect data on gut microbiota changes, infection rates, and GI symptoms over 14 weeks. The total duration includes treatment and follow-up, ensuring close observation of effects after stopping the probiotic or placebo.

Lactobacillus Reuteri Strain Combination in Children Treated With PPI