LGG for Prevention of Infectious Complications During PPI Treatment in Children

Study Overview
=================
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.

Official Title
-----------------
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.

Conditions
-----------------
Gastroesophageal Reflux Disease, Gastrointestinal Infections, Respiratory Tract Infections

Intervention / Treatment
-----------------
* Dietary Supplement: Lactobacillus GG


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus GG<br>Lactobacillus GG given for six weeks two times per day. | Dietary Supplement: Lactobacillus GG<br> <br> * Other names: Dicoflor;|
| Placebo Comparator: Placebo<br>Placebo two times per day for six weeks | Dietary Supplement: Lactobacillus GG<br> <br> * Other names: Dicoflor;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory tract infections | Number of upper and lower respiratory tract infections during intervention plus 3 months after termination of the intervention | 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 | up to 3 months after termination of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pneumonias | during intervention plus 3 months after termination of the intervention | 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. | up to 3 months after termination of intervention |