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Functional Dyspepsia Microbiome Study

Sponsor
Children's Mercy Hospital Kansas City (Other)
Overall Status
Completed
CT.gov ID
NCT02340312
Collaborator
University of Kansas Medical Center (Other)
40
Enrollment
1
Location
44
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: EGD
  • Other: Collection of Stool Specimens

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.

Study Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Duodenal Microbiome in Pediatric Functional Dyspepsia
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Sep 1, 2018

Outcome Measures

Primary Outcome Measures

  1. Microbiome Analysis [within 12 months from collection]

    Fecal samples and 8 mucosal biopsies (descending duodenum) will be obtained from each subject. Samples will be processed and DNA isolated per standard lab techniques.16S rDNA sequence analysis of microbial communities within patient samples will be analyzed utilizing our HiSeq 1500 rapid run technologies. We will perform 2 X 150 bp paired end sequencing which will give exceptional coverage (reads > 30,000). We will sequence the V4 region of 16s RNA (E. coli 515-806), which is the method optimized for Illumina HiSeq 1500 currently. We will also sequence simultaneously the V3 region of 16s RNA to provide a dual-control analysis of samples. Confirmatory PCR will be employed when appropriate. Data will be reported as total counts for each identified bacterial species.

  2. Inflammatory Cell Density [within 12 months from collection]

    Routine histology slides previously stained with hematoxylin and eosin will be utilized for determination of eosinophil density. IHC techniques will be utilized for determination of mast cell density. Serial 3-μm paraffin sections will be air dried and heat fixed on slides. The sections will be deparaffinized with xylene and iodine and rehydrated in a graded series of alcohol. Utilizing tryptase monoclonal mouse antihuman mast cell tryptase antibody (clone AA1, Dako, Carpinteria, CA), sections will be stained on an automated Dako Autostainer 3400 using Dako's LSAB+ kit with streptavidin conjugated to horseradish peroxidase. To determine density for each cell type, the entire specimen will be scanned to determine the subjective area of greatest involvement. Density will be determined by counting cells within 5 consecutive high-power fields (400X magnification). Peak and mean cell densities expressed as cells/hpf will be determined. This will be completed before study end.

  3. Immunohistochemistry (IHC) [within 12 months from collection]

    IHC staining will be performed and may include DCLK1, BDNF, TRPV1, and/or CRH-R1, respectively, depending on the results of an on-going pilot study. Staining intensity will be evaluated in a blinded fashion by a pathologist to assign scores for average IHC signal intensity (i.e. 0= none, 1= mild, 2= moderate, and 3= strong) as well as the percentage of tissue cells or fibers showing positive immunoreactivity. A sem-quantitative scoring system will be applied in which the final immunoreactive score will equal the product of the percentage of positive cells times the average staining intensity. Percentage of positive cells or fibers will be graded as follows: 0= negative-10%, 1= 11-33%, 2= 33-66%, and 3= > 67%. Immunoreactivity will be considered positive when the combined score ranges between 2-6 and negative with a score of 0-1. Other IHC stains may be performed should they become relevant as indicated by the literature. This will be performed before study end.

Secondary Outcome Measures

  1. T-scores for the BASC will be collected as part of this study on the Data Collection Form. [within 6 months from completion]

    This information is used to assess psychosocial information from the patient.This will be collected and recorded before study end.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Children's Mercy Hospital Kansas City Missouri United States 64108

Sponsors and Collaborators

  • Children's Mercy Hospital Kansas City
  • University of Kansas Medical Center

Investigators

  • Principal Investigator: Craig A Friesen, MD, Children's Mercy Hospital Kansas City

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Craig A. Friesen, MD, M.D. Divison Cheif Gastroenterology, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT02340312
Other Study ID Numbers:
  • 490390
First Posted:
Jan 16, 2015
Last Update Posted:
Oct 6, 2020
Last Verified:
Oct 1, 2020
Additional relevant MeSH terms:
Dyspepsia

Study Results

No Results Posted as of Oct 6, 2020