LGG for Prevention of Infectious Complications During PPI Treatment in Children

This study is not yet open for participant recruitment.

Verified January 2013 by Medical University of Warsaw

Sponsor:

Information provided by (Responsible Party):

Hanna Szajewska, Medical University of Warsaw

ClinicalTrials.gov Identifier:

NCT01782118

First received: January 21, 2013

Last updated: January 30, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 21, 2013

Last Updated Date

January 30, 2013

Start Date ^ICMJE

February 2013

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Respiratory tract infections [ Time Frame: up to 3 months after termination of intervention ] [ Designated as safety issue: No ]
Number of upper and lower respiratory tract infections during intervention plus 3 months after termination of the intervention
Gastrointestinal tract infections [ Time Frame: up to 3 months after termination of intervention ] [ Designated as safety issue: No ]
Number of gastrointestinal tract infections during during intervention plus 3 months after termination of the intervention

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01782118 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of pneumonias [ Time Frame: up to 3 months after termination of intervention ] [ Designated as safety issue: No ]
during intervention plus 3 months after termination of the intervention
Adverse events [ Time Frame: up to 3 months after termination of intervention ] [ Designated as safety issue: Yes ]
Number and character of adverse events during intervention plus 3 months after termination of the intervention.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

serum level of 25OHD [ Time Frame: at 6 weeks ] [ Designated as safety issue: Yes ]
serum level of ferritin [ Time Frame: at 6 weeks ] [ Designated as safety issue: Yes ]
Total iron binding capacity [ Time Frame: at 6 weeks ] [ Designated as safety issue: Yes ]
serum level of ferrum [ Time Frame: at 6 weeks ] [ Designated as safety issue: Yes ]
fecal calprotectin [ Time Frame: at 6 weeks ] [ Designated as safety issue: No ]

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

LGG for Prevention of Infectious Complications During PPI Treatment in Children

Official Title ^ICMJE

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Gastroesophageal Reflux Disease
Gastrointestinal Infections
Respiratory Tract Infections

Intervention ^ICMJE

Dietary Supplement: Lactobacillus GG

Other Name: Dicoflor

Study Arm (s)

Experimental: Lactobacillus GG
Lactobacillus GG given for six weeks two times per day.

Intervention: Dietary Supplement: Lactobacillus GG
Placebo Comparator: Placebo
Placebo two times per day for six weeks

Intervention: Dietary Supplement: Lactobacillus GG

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

July 2014

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Month to 5 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Katarzyna Krenke, MD	+48224523204	katarzynakrenke@gmail.com
Contact: Piotr Dziechciarz, MD	+48224523292	piotrdz@hotmail.com

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT01782118

Other Study ID Numbers ^ICMJE

1/2013

Has Data Monitoring Committee

Responsible Party

Hanna Szajewska, Medical University of Warsaw

Study Sponsor ^ICMJE

Medical University of Warsaw

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Medical University of Warsaw

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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