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

NCT02359604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-02-08

No results posted yet for this study

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.

Conditions

  • Gastroesophageal Reflux

Interventions

DRUG

PPI therapy

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

PROCEDURE

Stool sample

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

PROCEDURE

Stool sample

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

PROCEDURE

Stool sample

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

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Christoph Castellani, MD · Dept. of Pediatric and Adolescent Surgery, Medical University Graz

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-02-07
Completion
2017-02-07

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02359604 on ClinicalTrials.gov