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

Medical University of Graz

Status: Completed

Conditions: Gastroesophageal Reflux

Treatments: Drug: PPI therapy; Procedure: Stool sample

Study type: Interventional

Funder types: Other

Identifiers

NCT02359604

MUG-KCH-1

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 3 months to 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

neurological impairments

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Single Arm Study -microbiome

Other group

Description:

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.

Treatment:

Procedure: Stool sample

Procedure: Stool sample

Procedure: Stool sample

Drug: PPI therapy