LGG for Prevention of Infectious Complications During PPI Treatment in Children

Gastroesophageal Reflux Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01782118
• Other study ID #: 1/2013
• Status: Recruiting
• Phase: Phase 4
• First received: January 21, 2013
• Last updated: October 30, 2013
• Start date: February 2013
• Est. completion date: July 2014

Study information

• Verified date: October 2013
• Source: Medical University of Warsaw
• Contact: Katarzyna Krenke, MD
• Phone: +48224523204
• Email: katarzynakrenke[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 5 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Gastrointestinal Infections
• Infection
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Lactobacillus GG

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	serum level of 25OHD		at 6 weeks	Yes
Other	serum level of ferritin		at 6 weeks	Yes
Other	Total iron binding capacity		at 6 weeks	Yes
Other	serum level of ferrum		at 6 weeks	Yes
Other	fecal calprotectin		at 6 weeks	No
Primary	Respiratory tract infections	Number of upper and lower respiratory tract infections during intervention plus 3 months after termination of the intervention	up to 3 months after termination of intervention	No
Primary	Gastrointestinal tract infections	Number of gastrointestinal tract infections during during intervention plus 3 months after termination of the intervention	up to 3 months after termination of intervention	No
Secondary	Number of pneumonias	during intervention plus 3 months after termination of the intervention	up to 3 months after termination of intervention	No
Secondary	Adverse events	Number and character of adverse events during intervention plus 3 months after termination of the intervention.	up to 3 months after termination of intervention	Yes