LGG for Prevention of Infectious Complications During PPI Treatment in Children

Phase 4

• Conditions: Respiratory Tract Infections; Gastroesophageal Reflux Disease; Gastrointestinal Infections
• Interventions: Dietary Supplement: Lactobacillus GG

• 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

Arm && Interventions

Group	Intervention	Description
Lactobacillus GG	Lactobacillus GG	Lactobacillus GG given for six weeks two times per day.
Placebo	Lactobacillus GG	Placebo two times per day for six weeks

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