Trials / Unknown
UnknownNCT01782118
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.
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Medical University of Warsaw · Academic / Other
- Sex
- All
- Age
- 1 Month – 5 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Lactobacillus GG |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2014-06-01
- Completion
- 2014-07-01
- First posted
- 2013-02-01
- Last updated
- 2013-10-31
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT01782118. Inclusion in this directory is not an endorsement.