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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359604
• Other study ID #: MUG-KCH-1
• Status: Completed
• Phase: N/A
• First received: October 31, 2014
• Last updated: February 6, 2017
• Start date: October 2014
• Est. completion date: February 7, 2017

Study information

• Verified date: February 2017
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 7, 2017
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 1 Year

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

neurological impairments

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

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)
• Stool sample
Stool sample will be obtained 4 weeks after initiation of PPI (under PPI therapy)
• Stool sample
Stool sample will be obtained 8 weeks after termination of PPI therapy (after PPI therapy).

Locations

Country	Name	City	State
Austria	Department of Pediatric and Adolescent Surgery, Medical University of Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks