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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02359604

Enrollment

Registered

2015-02-10

Start date

2014-10-31

Completion date

2017-02-07

Last updated

2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Keywords

infant, ppi, proton pump inhibitor, microbiome, Microbiota

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.

Interventions

DRUGPPI 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

PROCEDUREStool sample

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Longitudinal study

Eligibility

Sex/Gender

ALL

Age

3 Months to 1 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

neurological impairments

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026