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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: PPI therapy; Procedure: Stool sample

• Registration Number: NCT02359604
• Lead Sponsor: Medical University of Graz

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2015-02-04
• Study First Posted: 2015-02-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Primary Completion: 2017-02-07
• Study Completion: 2017-02-07
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

neurological impairments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Study -microbiome	Stool sample	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.
Single Arm Study -microbiome	PPI therapy	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Pediatric and Adolescent Surgery, Medical University of Graz; 🇦🇹 Graz, Styria, Austria