Viewing Study NCT02359604



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Last Modification Date: 2024-10-26 @ 11:38 AM
Study NCT ID: NCT02359604
Status: COMPLETED
Last Update Posted: 2017-02-08
First Post: 2014-10-31

Brief Title: The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy a Pilot Study
Sponsor: Medical University of Graz
Organization: Medical University of Graz

Study Overview

Official Title: The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy a Pilot Study
Status: COMPLETED
Status Verified Date: 2017-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 1mgkgday 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 005 will be considered statistically significant
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None