Effect of Acid Suppression Medication on Pediatric Microbiome

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Omeprazole; Proton Pump Inhibitors

Criteria

Inclusion Criteria:

• Zero to 4 years old

• Being considered for PPI or H2RA treatment for refractory GERD

• Parent is able to give informed consent

Exclusion Criteria:

• Prevalent C. difficile infection (excluded via stool PCR at week 0)

• Use of systemic antibiotics within the past 90 days

• Use of acid suppression medications within the past 90 days (antacids allowed if none within the last 7 days)

• Increased risk for fracture due to vitamin D deficiency or other causes

• Chronic gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, microscopic colitis, malabsorptive conditions, short gut syndrome)

• Congenital deficiency in immunity (e.g., such as IgA deficiency)

• Cystic fibrosis

• Significant dynamic or uncontrolled comorbidity such as HIV or malignancy

• Use of medications with potential interaction with PPIs