Gut Microbiota Composition in Hispanic and Non-Hispanic Children.

NCT03990350 | Completed

• 1 other identifier: 1347478
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Gut Microbiome

Outcome Measures

Primary Outcomes (3)

• Metagenome of each patient's fecal sample

  sequence of all bacterial DNA and other organism's DNA in a sample

  through study completion, an average of 9 months

• Physical Activity

  Administer a validated physical activity questionnaire

  through study completion, an average of 9 months

• Food frequency questionnaire

  Administer a validated food frequency questionnaire

  through study completion, an average of 9 months

Study Arms (4)

Hispanic children with obesity

Other: Fecal Sample Collection; Other: Physical Activity Questionnaire; Other: Food Frequency Questionnaire; Other: 24-hour dietary recall diary

Hispanic children without obesity

Other: Fecal Sample Collection; Other: Physical Activity Questionnaire; Other: Food Frequency Questionnaire; Other: 24-hour dietary recall diary

Caucasian non-Hispanic children with obesity

Other: Fecal Sample Collection; Other: Physical Activity Questionnaire; Other: Food Frequency Questionnaire; Other: 24-hour dietary recall diary

Caucasian non-Hispanic children without obesity

Other: Fecal Sample Collection; Other: Physical Activity Questionnaire; Other: Food Frequency Questionnaire; Other: 24-hour dietary recall diary

Interventions

Fecal Sample Collection OTHER

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.

Caucasian non-Hispanic children with obesity; Caucasian non-Hispanic children without obesity; Hispanic children with obesity; Hispanic children without obesity

Physical Activity Questionnaire OTHER

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.

Caucasian non-Hispanic children with obesity; Caucasian non-Hispanic children without obesity; Hispanic children with obesity; Hispanic children without obesity

Food Frequency Questionnaire OTHER

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.

Caucasian non-Hispanic children with obesity; Caucasian non-Hispanic children without obesity; Hispanic children with obesity; Hispanic children without obesity

24-hour dietary recall diary OTHER

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; Caucasian non-Hispanic children without obesity; Hispanic children with obesity; Hispanic children without obesity

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours/AI duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Related Publications (16)

• Davis CD. The Gut Microbiome and Its Role in Obesity. Nutr Today. 2016 Jul-Aug;51(4):167-174. doi: 10.1097/NT.0000000000000167.

  PMID: 27795585 BACKGROUND

• Carrera-Quintanar L, Ortuno-Sahagun D, Franco-Arroyo NN, Viveros-Paredes JM, Zepeda-Morales AS, Lopez-Roa RI. The Human Microbiota and Obesity: A Literature Systematic Review of In Vivo Models and Technical Approaches. Int J Mol Sci. 2018 Nov 30;19(12):3827. doi: 10.3390/ijms19123827.

  PMID: 30513674 BACKGROUND

• Ochoa A, Berge JM. Home Environmental Influences on Childhood Obesity in the Latino Population: A Decade Review of Literature. J Immigr Minor Health. 2017 Apr;19(2):430-447. doi: 10.1007/s10903-016-0539-3.

  PMID: 28005241 BACKGROUND

• Lindsay AC, Wallington SF, Lees FD, Greaney ML. Exploring How the Home Environment Influences Eating and Physical Activity Habits of Low-Income, Latino Children of Predominantly Immigrant Families: A Qualitative Study. Int J Environ Res Public Health. 2018 May 14;15(5):978. doi: 10.3390/ijerph15050978.

  PMID: 29757941 BACKGROUND

• Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity Among Adults and Youth: United States, 2015-2016. NCHS Data Brief. 2017 Oct;(288):1-8.

  PMID: 29155689 BACKGROUND

• Del Chierico F, Abbatini F, Russo A, Quagliariello A, Reddel S, Capoccia D, Caccamo R, Ginanni Corradini S, Nobili V, De Peppo F, Dallapiccola B, Leonetti F, Silecchia G, Putignani L. Gut Microbiota Markers in Obese Adolescent and Adult Patients: Age-Dependent Differential Patterns. Front Microbiol. 2018 Jun 5;9:1210. doi: 10.3389/fmicb.2018.01210. eCollection 2018.

  PMID: 29922272 BACKGROUND

• Hou YP, He QQ, Ouyang HM, Peng HS, Wang Q, Li J, Lv XF, Zheng YN, Li SC, Liu HL, Yin AH. Human Gut Microbiota Associated with Obesity in Chinese Children and Adolescents. Biomed Res Int. 2017;2017:7585989. doi: 10.1155/2017/7585989. Epub 2017 Oct 29.

  PMID: 29214176 BACKGROUND

• Bolger AM, Lohse M, Usadel B. Trimmomatic: a flexible trimmer for Illumina sequence data. Bioinformatics. 2014 Aug 1;30(15):2114-20. doi: 10.1093/bioinformatics/btu170. Epub 2014 Apr 1.

  PMID: 24695404 BACKGROUND

• Wood DE, Salzberg SL. Kraken: ultrafast metagenomic sequence classification using exact alignments. Genome Biol. 2014 Mar 3;15(3):R46. doi: 10.1186/gb-2014-15-3-r46.

  PMID: 24580807 BACKGROUND

• Pereira MB, Wallroth M, Jonsson V, Kristiansson E. Comparison of normalization methods for the analysis of metagenomic gene abundance data. BMC Genomics. 2018 Apr 20;19(1):274. doi: 10.1186/s12864-018-4637-6.

  PMID: 29678163 BACKGROUND

• Li D, Liu CM, Luo R, Sadakane K, Lam TW. MEGAHIT: an ultra-fast single-node solution for large and complex metagenomics assembly via succinct de Bruijn graph. Bioinformatics. 2015 May 15;31(10):1674-6. doi: 10.1093/bioinformatics/btv033. Epub 2015 Jan 20.

  PMID: 25609793 BACKGROUND

• Hyatt D, LoCascio PF, Hauser LJ, Uberbacher EC. Gene and translation initiation site prediction in metagenomic sequences. Bioinformatics. 2012 Sep 1;28(17):2223-30. doi: 10.1093/bioinformatics/bts429. Epub 2012 Jul 12.

  PMID: 22796954 BACKGROUND

• Tatusov RL, Koonin EV, Lipman DJ. A genomic perspective on protein families. Science. 1997 Oct 24;278(5338):631-7. doi: 10.1126/science.278.5338.631.

  PMID: 9381173 BACKGROUND

• Dobin A, Davis CA, Schlesinger F, Drenkow J, Zaleski C, Jha S, Batut P, Chaisson M, Gingeras TR. STAR: ultrafast universal RNA-seq aligner. Bioinformatics. 2013 Jan 1;29(1):15-21. doi: 10.1093/bioinformatics/bts635. Epub 2012 Oct 25.

  PMID: 23104886 BACKGROUND

• Li B, Dewey CN. RSEM: accurate transcript quantification from RNA-Seq data with or without a reference genome. BMC Bioinformatics. 2011 Aug 4;12:323. doi: 10.1186/1471-2105-12-323.

  PMID: 21816040 BACKGROUND

• Vera-Becerra LE, Lopez ML, Kaiser LL. Relative validity of a tool to measure food acculturation in children of Mexican descent. Appetite. 2016 Feb 1;97:87-93. doi: 10.1016/j.appet.2015.11.014. Epub 2015 Nov 19.

  PMID: 26603574 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

One time fecal sample. Nucleic acid preservation is non-human organisms only.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew D Di Guglielmo, MD PhD

  Nemours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, General Pediatrics

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: June 18, 2019
• Study Start: June 14, 2019
• Primary Completion: February 28, 2020
• Study Completion: June 15, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)