LGG for Prevention of Infectious Complications During PPI Treatment in Children

Effectiveness of Lactobacillus GG in the Prevention of Gastrointestinal and Respiratory Tract Infections in Children With Gastroesophageal Reflux Disease Treated With Proton Pump Inhibitors: Randomized Double - Blind Placebo, Controlled Trial.

Background: Proton pump inhibitors (PPI) are effective for treating gastroesophageal reflux disease (GERD). However, they may be associated with an increased risk of gastrointestinal and respiratory tract infections.

Aim: To determine if Lactobacillus GG (LGG) is an effective adjunct to PPI for reducing the risk of gastrointestinal and respiratory tract infections in children with GERD.

Study design: Randomized, double-blind, placebo controlled trial.

Patients with GERD treated with PPI will be randomly assigned to receive LGG in dose of 10(9) Colony Forming Units (CFU) twice daily for 6 weeks or a comparable placebo twice daily for 6 weeks.

Inclusion Criteria:

• age <5,
• clinical symptoms of GERD
• treatment with proton pump inhibitors
• signed informed consent

Exclusion Criteria:

• treatment with PPI within the last 4 weeks for at least 2 weeks
• administration of probiotics within 7 days prior to the study
• acute or chronic respiratory tract infections
• acute or chronic gastrointestinal tract infections
• neurological disorders
• immunodeficiency