NCT02359604

The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 3 Months – 1 Year
• Healthy volunteers: Not accepted

Summary

Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the pH may lead to changes in the intestinal microbiome. Small series published in adults suggest a predominance of streptococci, a possible reason for increased incidences of pneumonia under PPI therapy. Studies in children are yet scarce. This study will include 20 infants. GERD will be verified by 24h-intraluminal impedance monitoring. All patients will have undergone conservative measures prior to initiation of PPI therapy (due to persisting symptoms). Children will receive a commercial PPI for 8 weeks (esomeprazole 1mg/kg/day). Stool samples will be collected before initiation of PPI, under PPI (4 weeks after initiation) and 8 weeks after discontinuing PPI therapy. The intestinal microbiome will be determined by 16S rDNA-based microbial community profiling by high-throughput pyrosequencing. Data will be compared by dependent non parametric test (Wilcoxon). P-values \<0.05 will be considered statistically significant.

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
DRUG	PPI therapy	PPI therapy (medication has FDA approval) for 8 weeks in children with proven GERD. The medication used (esomeprazole) in this trial is approved by the FDA
PROCEDURE	Stool sample	Stool sample will be obtained before initiation of PPI (before PPI therapy)
PROCEDURE	Stool sample	Stool sample will be obtained 4 weeks after initiation of PPI (under PPI therapy)
PROCEDURE	Stool sample	Stool sample will be obtained 8 weeks after termination of PPI therapy (after PPI therapy).

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-02-07
• Completion: 2017-02-07
• First posted: 2015-02-10
• Last updated: 2017-02-08

Locations

1 site across 1 country: Austria