Clinical trial NCT02340312: Functional Dyspepsia Microbiome Study
Official title: Evaluation of the Duodenal Microbiome in Pediatric Functional Dyspepsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Dyspepsia
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
Collaborators: name: University of Kansas Medical Center
First posted: 2015-01-16
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolecents ages 8 to 17 inclusive that have been diagonsed with functional dyspepsia and are scheduled to have a EGD with biopsy.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbiome Analysis
timeFrame: within 12 months from collection
measure: Inflammatory Cell Density
timeFrame: within 12 months from collection
measure: Immunohistochemistry (IHC)
timeFrame: within 12 months from collection
Secondary outcomes:
measure: T-scores for the BASC will be collected as part of this study on the Data Collection Form.
timeFrame: within 6 months from completion
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Craig A Friesen, MD
role: PRINCIPAL_INVESTIGATOR
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