Functional Dyspepsia Microbiome Study

Children's Mercy Hospital Kansas City

Status: Completed

Conditions: Functional Dyspepsia

Treatments: Procedure: EGD; Other: Collection of Stool Specimens

Study type: Observational

Funder types: Other

Identifiers

NCT02340312

490390

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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