LGG for Prevention of Infectious Complications During PPI Treatment in Children

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

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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