NCT02340312

Functional Dyspepsia Microbiome Study

Evaluation of the Duodenal Microbiome in Pediatric Functional Dyspepsia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Children's Mercy Hospital Kansas City · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of the current 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. SPECIFIC AIMS 1. To 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. To determine if the frequencies or proportions of specific bacteria or bacteria phyla differ between children with and without PDS. 3. To determine bi-variate correlations between bacteria/phyla frequency, bacteria/ phyla proportion, anxiety scores, and mucosal biomarkers, respectively.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
PROCEDURE	EGD	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.
OTHER	Collection of Stool Specimens	We will be collecting stool samples from each participant for research purposes. Within two weeks after EGD tissue collection.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2015-01-16
• Last updated: 2020-10-06

Locations

1 site across 1 country: United States