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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01782118

Enrollment

120

Registered

2013-02-01

Start date

2013-02-28

Completion date

2014-07-31

Last updated

2013-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease, Gastrointestinal Infections, Respiratory Tract Infections

Brief 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.

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus GG

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Months to 5 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Respiratory tract infections	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	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

Measure	Time frame	Description
Number of pneumonias	up to 3 months after termination of intervention	during intervention plus 3 months after termination of the intervention
Adverse events	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

Measure	Time frame
serum level of 25OHD	at 6 weeks
fecal calprotectin	at 6 weeks
serum level of ferritin	at 6 weeks
Total iron binding capacity	at 6 weeks
serum level of ferrum	at 6 weeks

Countries

Poland

Contacts

Primary ContactKatarzyna Krenke, MD

katarzynakrenke@gmail.com+48224523204

Backup ContactPiotr Dziechciarz, MD

piotrdz@hotmail.com+48224523292

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026