LGG for Prevention of Infectious Complications During PPI Treatment in Children

M

Medical University of Warsaw

Status and phase

Unknown
Phase 4

Conditions

Gastroesophageal Reflux Disease
Respiratory Tract Infections
Gastrointestinal Infections

Treatments

Dietary Supplement: Lactobacillus GG

Study type

Interventional

Funder types

Other

Identifiers

NCT01782118
1/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

1 month to 5 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 2 patient groups, including a placebo group

Lactobacillus GG
Experimental group
Description:
Lactobacillus GG given for six weeks two times per day.
Treatment:
Dietary Supplement: Lactobacillus GG
Placebo
Placebo Comparator group
Description:
Placebo two times per day for six weeks
Treatment:
Dietary Supplement: Lactobacillus GG

Trial contacts and locations

1

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Central trial contact

Katarzyna Krenke, MD; Piotr Dziechciarz, MD

Data sourced from clinicaltrials.gov

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