LGG for Prevention of Infectious Complications During PPI Treatment in Children

Phase 4

• Conditions: Respiratory Tract Infections; Gastroesophageal Reflux Disease; Gastrointestinal Infections

• Registration Number: NCT01782118
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2013-01-21
• Study First Submitted QC: 2013-01-30
• Study Start: 2013-02
• Study First Posted: 2013-02-01
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31
• Primary Completion: 2014-06
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory tract infections	up to 3 months after termination of intervention	Number of upper and lower respiratory tract infections during intervention plus 3 months after termination of the intervention
Gastrointestinal tract infections	up to 3 months after termination of intervention	Number of gastrointestinal tract infections during during intervention plus 3 months after termination of the intervention

Secondary Outcome Measures

Name	Time	Method
Number of pneumonias	up to 3 months after termination of intervention	during intervention plus 3 months after termination of the intervention
Adverse events	up to 3 months after termination of intervention	Number and character of adverse events during intervention plus 3 months after termination of the intervention.

Trial Locations

Locations (1)

Medical University of Warsaw; 🇵🇱 Warsaw, Poland