LGG for Prevention of Infectious Complications During PPI Treatment in Children
October 30, 2013 updated by: Hanna Szajewska, Medical University of Warsaw
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.
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Warsaw, Poland, 02-091
- Recruiting
- Medical University of Warsaw
-
Contact:
- Katarzyna Krenlke, MD
- Phone Number: +48224523204
- Email: katarzynakrenke@gmail.com
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Contact:
- Piotr Dziechciarz, MD
- Phone Number: +48224523292
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Principal Investigator:
- Katarzyna Krenke, MD
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Sub-Investigator:
- Piotr Dziechciarz, MD
-
Sub-Investigator:
- Hania Szajewska, MD
-
Sub-Investigator:
- Andrea Horvath, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lactobacillus GG
Lactobacillus GG given for six weeks two times per day.
|
Other Names:
|
|
Placebo Comparator: Placebo
Placebo two times per day for six weeks
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory tract infections
Time Frame: 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
|
up to 3 months after termination of intervention
|
|
Gastrointestinal tract infections
Time Frame: up to 3 months after termination of intervention
|
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
Time Frame: up to 3 months after termination of intervention
|
during intervention plus 3 months after termination of the intervention
|
up to 3 months after termination of intervention
|
|
Adverse events
Time Frame: up to 3 months after termination of intervention
|
Number and character of adverse events during intervention plus 3 months after termination of the intervention.
|
up to 3 months after termination of intervention
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
serum level of 25OHD
Time Frame: at 6 weeks
|
at 6 weeks
|
|
serum level of ferritin
Time Frame: at 6 weeks
|
at 6 weeks
|
|
Total iron binding capacity
Time Frame: at 6 weeks
|
at 6 weeks
|
|
serum level of ferrum
Time Frame: at 6 weeks
|
at 6 weeks
|
|
fecal calprotectin
Time Frame: at 6 weeks
|
at 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Anticipated)
June 1, 2014
Study Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
January 21, 2013
First Submitted That Met QC Criteria
January 30, 2013
First Posted (Estimate)
February 1, 2013
Study Record Updates
Last Update Posted (Estimate)
October 31, 2013
Last Update Submitted That Met QC Criteria
October 30, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1/2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.