CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
EGD +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02340312
NCT02340312N/ACompleted

Evaluation of the Duodenal Microbiome in Pediatric Functional Dyspepsia

Children's Mercy Hospital Kansas City·observational·Posted Jan 16, 2015·Updated Oct 6, 2020

In Brief

An observational study evaluating EGD and Collection of Stool Specimens for Functional Dyspepsia. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Recurrent abdominal pain has long been acknowledged to be the most common chronic pain entities in children. The purpose of this study is to describe the microbiome in children with FD and to explore relationships between the microbiome and postprandial distress syndrome, anxiety scores, and mucosal biomarkers or anxiety. The specific goals of this study are to: 1) Determine the frequencies and relative proportions for specific bacteria or bacteria phyla in children with FD in both duodenal mucosal specimens and stool samples. 2) Determine if the frequencies or proportions of specific bacteria or bacteria phyla differ between children with and without PDS. 3) Determine bi-variate correlations between bacteria/phyla frequency, bacteria/phyla proportions, anxiety scores, and mucosal biomarkers, respectively.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 16, 2015
Enrollment StartJan 1, 2015
Primary CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.5 years ago

Interventions

EGDprocedure

In this study patients are being scoped(EGD) as standard of care and being asked to allow .5 aggregate of tissue biopsy to be taken for research purposes.

Collection of Stool Specimensother

We will be collecting stool samples from each participant for research purposes. Within two weeks after EGD tissue collection.