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Trial record 2 of 2 for:    29155689 [PUBMED-IDS]

Gut Microbiota Composition in Hispanic and Non-Hispanic Children.

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ClinicalTrials.gov Identifier: NCT03990350
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Di Guglielmo, Nemours Children's Clinic

Brief Summary:
The human gastrointestinal (GI) tract is filled with millions of bacteria that can affect our health. These bacteria are linked with our overall health including obesity risk. In the United States the Hispanic population is one of the ethnic groups at higher risk of developing obesity. In this study the team will investigate differences in the GI bacterial composition between Hispanic and Caucasian children, and potentially demonstrate a correlation between the composition of metagenome and a higher risk to develop obesity. This will be done by collecting stool samples and comparing the bacteria found in the stool of Hispanic children (with and without obesity) and Caucasian children (with and without obesity.

Condition or disease Intervention/treatment
Obesity Other: Fecal Sample Collection Other: Physical Activity Questionnaire Other: Food Frequency Questionnaire Other: 24-hour dietary recall diary

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of the Gut Microbiota Composition in Caucasian Hispanic and Caucasian Non-Hispanic Children With and Without Obesity
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : June 30, 2020

Group/Cohort Intervention/treatment
Hispanic children with obesity Other: Fecal Sample Collection
With permission from the parent/guardian, stool collected in a sterile container will be brought within 12 hours of defecation from home or the outpatient clinic to a separate clinical laboratory where feces will be collected through use of FLOQswab brush x 3 (Copan Diagnostics, Murrieta, CA) The swabs will be pre-labeled with a de-identified code reflecting patient number, sample number, and date and the sample will be placed into dry ice then transferred to a -80 degrees Celsius freezer until retrieval by the research staff for transfer to CHOP Microbiome Center.

Other: Physical Activity Questionnaire
At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the Physical Activity Questionnaire (Physical Activity Questionnaire for Older Children) with the subject and parent.

Other: Food Frequency Questionnaire
At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the Food Frequency Questionnaire with the subject and parent.

Other: 24-hour dietary recall diary
At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the 24-hour dietary recall diary with the subject and parent.

Hispanic children without obesity Other: Fecal Sample Collection
With permission from the parent/guardian, stool collected in a sterile container will be brought within 12 hours of defecation from home or the outpatient clinic to a separate clinical laboratory where feces will be collected through use of FLOQswab brush x 3 (Copan Diagnostics, Murrieta, CA) The swabs will be pre-labeled with a de-identified code reflecting patient number, sample number, and date and the sample will be placed into dry ice then transferred to a -80 degrees Celsius freezer until retrieval by the research staff for transfer to CHOP Microbiome Center.

Other: Physical Activity Questionnaire
At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the Physical Activity Questionnaire (Physical Activity Questionnaire for Older Children) with the subject and parent.

Other: Food Frequency Questionnaire
At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the Food Frequency Questionnaire with the subject and parent.

Other: 24-hour dietary recall diary
At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the 24-hour dietary recall diary with the subject and parent.

Caucasian non-Hispanic children with obesity Other: Fecal Sample Collection
With permission from the parent/guardian, stool collected in a sterile container will be brought within 12 hours of defecation from home or the outpatient clinic to a separate clinical laboratory where feces will be collected through use of FLOQswab brush x 3 (Copan Diagnostics, Murrieta, CA) The swabs will be pre-labeled with a de-identified code reflecting patient number, sample number, and date and the sample will be placed into dry ice then transferred to a -80 degrees Celsius freezer until retrieval by the research staff for transfer to CHOP Microbiome Center.

Other: Physical Activity Questionnaire
At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the Physical Activity Questionnaire (Physical Activity Questionnaire for Older Children) with the subject and parent.

Other: Food Frequency Questionnaire
At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the Food Frequency Questionnaire with the subject and parent.

Other: 24-hour dietary recall diary
At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the 24-hour dietary recall diary with the subject and parent.

Caucasian non-Hispanic children without obesity Other: Fecal Sample Collection
With permission from the parent/guardian, stool collected in a sterile container will be brought within 12 hours of defecation from home or the outpatient clinic to a separate clinical laboratory where feces will be collected through use of FLOQswab brush x 3 (Copan Diagnostics, Murrieta, CA) The swabs will be pre-labeled with a de-identified code reflecting patient number, sample number, and date and the sample will be placed into dry ice then transferred to a -80 degrees Celsius freezer until retrieval by the research staff for transfer to CHOP Microbiome Center.

Other: Physical Activity Questionnaire
At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the Physical Activity Questionnaire (Physical Activity Questionnaire for Older Children) with the subject and parent.

Other: Food Frequency Questionnaire
At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the Food Frequency Questionnaire with the subject and parent.

Other: 24-hour dietary recall diary
At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the 24-hour dietary recall diary with the subject and parent.




Primary Outcome Measures :
  1. Metagenome of each patient's fecal sample [ Time Frame: through study completion, an average of 9 months ]
    sequence of all bacterial DNA and other organism's DNA in a sample

  2. Physical Activity [ Time Frame: through study completion, an average of 9 months ]
    Administer a validated physical activity questionnaire

  3. Food frequency questionnaire [ Time Frame: through study completion, an average of 9 months ]
    Administer a validated food frequency questionnaire


Biospecimen Retention:   Samples With DNA
One time fecal sample. Nucleic acid preservation is non-human organisms only.


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The investigators will recruit and enroll 4 cohorts including 6 Hispanic children with obesity, 6 Hispanic children without obesity, 6 Caucasian non-Hispanic children with obesity and 6 Caucasian non-Hispanic children without obesity. Obesity will be defined as a BMI >95%. Enrollment age will be between 6-12 years of age.
Criteria

Inclusion Criteria:

  • Caucasian non-Hispanic and Hispanic Children with and without obesity.

Exclusion Criteria:

  • if the subject has a current or recent (within the past 14 days) gastrointestinal infection (viral, bacterial, or fungal)
  • Known to have gastrointestinal mucosal disease or have clinically significant constipation.
  • Children taking probiotics.
  • History of antibiotic use within the last 6 months at the time of recruitment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03990350


Contacts
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Contact: David Garcia, MD 302-651-5928 David.garcia@nemours.org
Contact: Matthew D Di Guglielmo, MD, PhD Matthew.diguglielmo@nemours.org

Locations
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United States, Delaware
Nemours/AI duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Matthew Di Guglielmo       mdigugli@nemours.org   
Contact: David Garcia       david.garcia@nemours.org   
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
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Principal Investigator: Matthew D Di Guglielmo, MD PhD Nemours

Publications:
Li B, Dewey CN. RSEM: Accurate transcript quantification from RNA-seq data with or without a reference genome. Bioinforma Impact Accurate Quantif Proteomic Genet Anal Res. 2014;41-74.

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Responsible Party: Matthew Di Guglielmo, Chief, General Pediatrics, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT03990350     History of Changes
Other Study ID Numbers: 1347478
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Di Guglielmo, Nemours Children's Clinic:
Gut Microbiome
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms