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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
120
Medical University of Warsaw
Warsaw, Poland
RECRUITINGRespiratory tract infections
Number of upper and lower respiratory tract infections during intervention plus 3 months after termination of the intervention
Time frame: up to 3 months after termination of intervention
Gastrointestinal tract infections
Number of gastrointestinal tract infections during during intervention plus 3 months after termination of the intervention
Time frame: up to 3 months after termination of intervention
Number of pneumonias
during intervention plus 3 months after termination of the intervention
Time frame: up to 3 months after termination of intervention
Adverse events
Number and character of adverse events during intervention plus 3 months after termination of the intervention.
Time frame: up to 3 months after termination of intervention
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