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OpenTrials
Completed

NCT Number: NCT02359604

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.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

3 month–1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric and Adolescent Surgery, Medical University of Graz

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

symptomatic GERD (proved by impedance monitoring) despite conservative treatment requiring PPI therapy

Exclusion criteria

neurological impairments

Treatment and study plan

PPI therapy

Drug

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

Other names: esomeprazole

Stool sample

Procedure

Stool sample will be obtained before initiation of PPI (before PPI therapy)

Primary outcomes

  1. microbial community profiling of stool to include: rate [or prevalence] of specific phyla [i.e. Proteobacteria and Firmicutes], contributing to fecal microbial communities

    Time frame: 16 weeks

    The change of intestinal microbiota under PPI therapy will be examined.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2015
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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