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.
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2013
CompletedFirst Posted
Study publicly available on registry
February 1, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedOctober 31, 2013
October 1, 2013
1.3 years
January 21, 2013
October 30, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Number of pneumonias
up to 3 months after termination of intervention
Adverse events
up to 3 months after termination of intervention
Other Outcomes (5)
serum level of 25OHD
at 6 weeks
serum level of ferritin
at 6 weeks
Total iron binding capacity
at 6 weeks
- +2 more other outcomes
Study Arms (2)
Lactobacillus GG
EXPERIMENTALLactobacillus GG given for six weeks two times per day.
Placebo
PLACEBO COMPARATORPlacebo two times per day for six weeks
Interventions
Eligibility Criteria
You may qualify if:
- age \<5,
- clinical symptoms of GERD
- treatment with proton pump inhibitors
- signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Warsaw
Warsaw, 02-091, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 21, 2013
First Posted
February 1, 2013
Study Start
February 1, 2013
Primary Completion
June 1, 2014
Study Completion
July 1, 2014
Last Updated
October 31, 2013
Record last verified: 2013-10