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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
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Gastrointestinal Infections
Respiratory Tract Infections
 Dietary Supplement: Lactobacillus GG
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactobacillus GG
Lactobacillus GG given for six weeks two times per day.
 Dietary Supplement: Lactobacillus GG
Other Name: Dicoflor
Placebo Comparator: Placebo
Placebo two times per day for six weeks
 Dietary Supplement: Lactobacillus GG
Other Name: Dicoflor

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.

  Eligibility

Ages Eligible for Study:   1 Month to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782118

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

Locations
Poland
Medical University of Warsaw Not yet recruiting
Warsaw, Poland, 02-091
Contact: Katarzyna Krenlke, MD     +48224523204     katarzynakrenke@gmail.com    
Contact: Piotr Dziechciarz, MD     +48224523292        
Principal Investigator: Katarzyna Krenke, MD            
Sub-Investigator: Piotr Dziechciarz, MD            
Sub-Investigator: Hania Szajewska, MD            
Sub-Investigator: Andrea Horvath, MD            
Sponsors and Collaborators
Medical University of Warsaw
  More Information

No publications provided

Responsible Party: Hanna Szajewska, Professor, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01782118     History of Changes
Other Study ID Numbers: 1/2013
Study First Received: January 21, 2013
Last Updated: January 30, 2013
Health Authority: Poland: Ethics Committee

Additional relevant MeSH terms:
Gastroesophageal Reflux
Respiratory Tract Infections
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Infection
Respiratory Tract Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013