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

Medical University of Graz12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux

Interventions

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

Stool samplePROCEDURE

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

Stool samplePROCEDURE

Stool sample will be obtained 4 weeks after initiation of PPI (under PPI therapy)

Stool samplePROCEDURE

Stool sample will be obtained 8 weeks after termination of PPI therapy (after PPI therapy).

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 1 Year

Medical Language ↔ Plain English

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

Locations (1)

Department of Pediatric and Adolescent Surgery, Medical University of Graz

Graz, Styria, Austria

Outcomes

Primary Outcomes

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.

Time frame: 16 weeks

Data from ClinicalTrials.gov

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