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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
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


Further study details as provided by Hanna Szajewska, Medical University of Warsaw:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782118


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

Locations
Poland
Medical University of Warsaw 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

Responsible Party: Hanna Szajewska, Professor, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01782118     History of Changes
Other Study ID Numbers: 1/2013
First Submitted: January 21, 2013
First Posted: February 1, 2013
Last Update Posted: October 31, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Infection
Communicable Diseases
Gastroesophageal Reflux
Respiratory Tract Infections
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Respiratory Tract Diseases