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LGG for Prevention of Infectious Complications During PPI Treatment in Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Hanna Szajewska, Medical University of Warsaw.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01782118
First Posted: February 1, 2013
Last Update Posted: October 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanna Szajewska, Medical University of Warsaw
January 21, 2013
February 1, 2013
October 31, 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 ]
    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 ]
    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 ]
    during intervention plus 3 months after termination of the 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.
Same as current
  • serum level of 25OHD [ Time Frame: at 6 weeks ]
  • serum level of ferritin [ Time Frame: at 6 weeks ]
  • Total iron binding capacity [ Time Frame: at 6 weeks ]
  • serum level of ferrum [ Time Frame: at 6 weeks ]
  • fecal calprotectin [ Time Frame: at 6 weeks ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
 
Unknown status
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
Sexes Eligible for Study: All
1 Month to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT01782118
1/2013
No
Not Provided
Not Provided
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