Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
40 participants
Study Classification
OBSERVATIONAL
Study Start Date
2015-01-31
Study Completion Date
2018-09-30
Brief Summary
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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.
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Detailed Description
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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.
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
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Functional Dyspepsia
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
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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.
Intervention Type
PROCEDURE
Collection of Stool Specimens
We will be collecting stool samples from each participant for research purposes. Within two weeks after EGD tissue collection.
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* Use of systemic steroid or immunomodulating drug within 8 weeks of enrollment
Minimum Eligible Age
8 Years
Maximum Eligible Age
17 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Kansas Medical Center
OTHER
Sponsor Role
collaborator
Children's Mercy Hospital Kansas City
OTHER
Sponsor Role
lead
Responsible Party
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Craig A. Friesen, MD
M.D. Divison Cheif Gastroenterology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Craig A Friesen, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Locations
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The Children's Mercy Hospital
Kansas City, Missouri, United States
Site Status
Countries
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United States
References
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Other Identifiers
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490390
Identifier Type: -
Identifier Source: org_study_id
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