Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

LGG for Prevention of Infectious Complications During PPI Treatment in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 30, 2013
Last verified: October 2013

January 21, 2013
October 30, 2013
February 2013
June 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01782118 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
  • 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 ]
Same as current
 
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Gastroesophageal Reflux Disease
  • Gastrointestinal Infections
  • Respiratory Tract Infections
Dietary Supplement: Lactobacillus GG
Other Name: Dicoflor
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
July 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
1 Month to 5 Years
No
Contact: Katarzyna Krenke, MD +48224523204 katarzynakrenke@gmail.com
Contact: Piotr Dziechciarz, MD +48224523292 piotrdz@hotmail.com
Poland
 
NCT01782118
1/2013
No
Hanna Szajewska, Medical University of Warsaw
Medical University of Warsaw
Not Provided
Not Provided
Medical University of Warsaw
October 2013

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