Conditions: Clostridium Difficile Infection
Keywords: Clostridium Difficile Infection Proton Pump Inhibitors Histamine-2 Receptor Antagonists Gastroesophageal Reflux Disease
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 7
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Open-label, with all subjects receiving omeprazole arm 2: Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.)

Interventions: intervention 1: Omeprazole (suspension) intervention 2: Lifestyle Modification
Intervention descriptions: intervention 1: 1 mg/kg/day intervention 2: Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed

Protocol document: