NCT02016820

Effect of Acid Suppression Medication on Pediatric Microbiome

Effect of Proton Pump Inhibitors on the Colonic Microbiome in Children

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 0 Years – 4 Years
• Healthy volunteers: Not accepted

Summary

The colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the pediatric colonic microbiome are unknown. This study will determine whether acid suppression with these medications affects the microbiome of otherwise healthy children who are prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the duration and magnitude of microbiome changes.

Detailed description

Otherwise healthy children age 0-4 years old who are being considered for acid suppressive therapy for GERD will be eligible for this study. Subjects donate samples before and after being treated with PPIs or H2RAs (must donate at least 2 baseline pre-PPI samples to be eligible for final analysis). 30 total children who complete the study (anticipated 10 who receive lifestyle modification and 20 who receive PPIs or H2RAs). All children will donate 6 stools on or about weeks 0, 4, 12, 20, 38, and 64. The primary outcome will be a significant change in the overall diversity of the colonic microbiome after 8 weeks of PPIs or H2RAs (i.e., from week 12 to week 4), compared to after 4 weeks of lifestyle management.

Conditions

• Clostridium Difficile Infection

Interventions

Type	Name	Description
DRUG	Omeprazole (suspension)	1 mg/kg/day
OTHER	Lifestyle Modification	Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2013-12-20
• Last updated: 2023-12-26
• Results posted: 2023-12-26

Locations

1 site across 1 country: United States