Gastroesophageal Reflux Clinical Trial
Official title:
The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study
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.
n/a
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