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Effect of Acid Suppression Medication on Pediatric Microbiome

NCT02016820 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-12-26

Study results available
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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.

Conditions

  • Clostridium Difficile Infection

Interventions

DRUG

Omeprazole (suspension)

1 mg/kg/day

OTHER

Lifestyle Modification

Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed

Sponsors & Collaborators

Principal Investigators

  • Julian S Abrams, MD, MS · Columbia University

  • Daniel E Freedberg, MD, MS · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02016820 on ClinicalTrials.gov