Ignite Creation Date:
2024-05-06 @ 1:20 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01782118
Status:
UNKNOWN
Last Update Posted:
2013-10-31
First Post:
2013-01-21
Brief Title:
LGG for Prevention of Infectious Complications During PPI Treatment in Children
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2013-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 109 Colony Forming Units CFU twice daily for 6 weeks or a comparable placebo twice daily for 6 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None