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Composition and Collection Feasibility of Gut Microbiota in Children With and Without Obesity

31. juli 2019 opdateret af: University of Illinois College of Medicine at Peoria
Adults with obesity have an imbalance of bacteria in their intestines which may contribute to weight gain and diseases related to obesity. Restoring the balance of these bacteria (the "microbiota") could help reduce weight and related diseases. However, little is known about this imbalance in children with obesity. This research study will map out the compositions of the gut microbiota of children and compare them with those of children who have healthy weights and different degrees of obesity. This project will also measure the amounts of fatty acids in the stools which are an indication of how efficiently the intestines absorb calories from food. If an imbalance is detected in children with obesity, then this information can help researchers test ways to restore the gut microbiota with hopes of reducing weight and some of its related health problems.

Studieoversigt

Status

Ukendt

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Forventet)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Peoria, Illinois, Forenede Stater, 61637
        • University of Illinois College of Medicine at Peoria

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 år til 12 år (Barn)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

150 participants will be recruited from 4 primary care sites (2 urban and two rural) and a tertiary pediatric weight management clinic (PWMC) located in Central Illinois over an 18 month period. Enrollment will equally represent urban and rural lean participant living environments.

Beskrivelse

Inclusion Criteria:

1) patients aged 5-12 years

Exclusion Criteria:

  1. patient who have received either oral or parenteral antibiotics in the last 3 months
  2. patients who have a diagnosed immunodeficiency
  3. patients who are on medications that modulate the immune system including systemic prednisone and biologics
  4. patients who have a gastrointestinal condition which is known to alter the gut flora such as inflammatory bowel disease, chronic diarrhea, celiac disease and eosinophilic gastroenteritis diseases
  5. patients who have taken proton pump inhibitors in the last 3 months
  6. patients who have taken probiotics in the last 6 months.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Healthy Weight
Participants with BMI < 95th percentile
Obese
Participants with BMI > or = 95th percentile

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Microbiota Composition
Tidsramme: Over 2 years
High-throughput sequencing targeting the 16S rRNA gene will be used to detect and identify bacteria in fecal samples. DNA extraction and library preparation will be performed at the University of Illinois College of Medicine at Peoria, and libraries will be subjected to 16S rDNA sequencing (approximately 10k reads will be obtained per sample) on a MiSeq instrument. Using 10k reads per sample provides stable patterns for human stool microbiota. The 16S data will provide information about the presence and abundance of bacteria, and will be analyzed with Qiime, an open source bioinformatics package.
Over 2 years
Short Chain Fatty Acid Content
Tidsramme: Over 2 years
Gas Chromatography will be used to measure SCFA amounts, specifically acetate, butyrate, proprionate. Preserved aliquot samples will be analyzed on Agilent GC/MS system (6890GC/5973 MS with 7683B autosampler) with gas chromatography performed on a ZB-WAX (30 m×0.32 mm I.D., 0.25um film thickness) capillary column (Phenomenex, Torrance, CA). The inlet and MSD interface temperatures will both be 250°C, with the ion source temperature adjusted to 230°C. The helium carrier gas will be kept at a constant flow rate of 3.2 ml/min. The temperature program is: initial 2-min isothermal heating at 80°C, followed by an oven temperature increase of 20°C/min to 110°C, then 10°C/min to 130°C, and then 35°C/min to 255°C. Mass spectra will again be recorded in the m/z 50-300 scanning range.
Over 2 years
Specimen Quality
Tidsramme: Over 2 years
Technical factors, which may affect microbial compositions (such as times of specimen collection, home freezer storage removal, shipping, and arrival) will be recorded as independent variables. To estimate and minimize the effect of technical variables, principal component analysis will be used and the study will follow the International Human Microbiome Standards
Over 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Illinois College of Medicine at Peoria

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. marts 2017

Primær færdiggørelse (Faktiske)

31. december 2018

Studieafslutning (Forventet)

31. december 2019

Datoer for studieregistrering

Først indsendt

9. maj 2017

Først indsendt, der opfyldte QC-kriterier

9. maj 2017

Først opslået (Faktiske)

11. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1001223

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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