The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study
NCT ID: NCT02359604
Last Updated: 2017-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2014-10-31
2017-02-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Single Arm Study -microbiome
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.
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
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).
Interventions
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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
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Months
1 Year
ALL
No
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Castellani Christoph, MD
PD Dr. med.
Principal Investigators
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Christoph Castellani, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Pediatric and Adolescent Surgery, Medical University Graz
Locations
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Department of Pediatric and Adolescent Surgery, Medical University of Graz
Graz, Styria, Austria
Countries
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References
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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.
Other Identifiers
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MUG-KCH-1
Identifier Type: -
Identifier Source: org_study_id
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