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

NCT02359604 | Completed DMC

• 1 other identifier: MUG-KCH-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Keywords

infant; ppi; proton pump inhibitor; microbiome; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single Arm Study -microbiome

OTHER

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.

Drug: PPI therapy; Procedure: Stool sample

Interventions

PPI therapy DRUG

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

Also known as: esomeprazole

Single Arm Study -microbiome

Stool sample PROCEDURE

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

Single Arm Study -microbiome

Eligibility Criteria

• Age: 3 Months - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• neurological impairments

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Pediatric and Adolescent Surgery, Medical University of Graz

Graz, Styria, 8036, Austria

Location

Related Publications (1)

• Castellani C, Singer G, Kashofer K, Huber-Zeyringer A, Flucher C, Kaiser M, Till H. The Influence of Proton Pump Inhibitors on the Fecal Microbiome of Infants with Gastroesophageal Reflux-A Prospective Longitudinal Interventional Study. Front Cell Infect Microbiol. 2017 Oct 11;7:444. doi: 10.3389/fcimb.2017.00444. eCollection 2017.

  PMID: 29075620 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Christoph Castellani, MD

  Dept. of Pediatric and Adolescent Surgery, Medical University Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Model Details: Longitudinal study

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: February 10, 2015
• Study Start: October 1, 2014
• Primary Completion: February 7, 2017
• Study Completion: February 7, 2017
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

AU (1)