Functional Dyspepsia Microbiome Study

Completed

Conditions studied: Functional Dyspepsia

In brief

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.

Key facts

Study ID

NCT02340312

Run by

Children's Mercy Hospital Kansas City

People needed

40

Starts

2015-01-01

Expected to finish

2018-09-01

Last updated by the study team

2020-10-06

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of FD as determined by the GI physician in accordance with Rome III criteria
• Age 8-17 years inclusive
• Scheduled for upper endoscopy as part of routine care after failing to respond to acid suppression therapy

You may not qualify if…

• Use of oral antibiotic or probiotic within 8 weeks prior to enrollment
• Use of systemic steroid or immunomodulating drug within 8 weeks of enrollment

Where it is running

• The Children's Mercy Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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