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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Drug: PPI therapy
* Procedure: Stool sample
* Procedure: Stool sample
* Procedure: Stool sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic GERD (proved by impedance monitoring) despite conservative treatment requiring PPI therapy Exclusion Criteria: neurological impairments

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Longitudinal study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm Study -microbiome<br>This is a single-arm study. The patients will serve as their own controls. The PPI administered for PPI-therapy is already FDA approved. A stool sample will be obtained for intestinal microbiome testing before PPI, under PPI and after PPI therapy. | Drug: PPI therapy<br>* 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<br>* Other names: esomeprazole;Procedure: Stool sample<br>* Stool sample will be obtained before initiation of PPI (before PPI therapy)<br>Procedure: Stool sample<br>* Stool sample will be obtained 4 weeks after initiation of PPI (under PPI therapy)<br>Procedure: Stool sample<br>* Stool sample will be obtained 8 weeks after termination of PPI therapy (after PPI therapy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microbial community profiling of stool to include: rate [or prevalence] of specific phyla [i.e. Proteobacteria and Firmicutes], contributing to fecal microbial communities | The change of intestinal microbiota under PPI therapy will be examined. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, ppi, proton pump inhibitor, microbiome, Microbiota