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

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.

Study Overview

• Status: Unknown
• Conditions: Childhood Obesity

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Peoria, Illinois, United States, 61637
      • University of Illinois College of Medicine at Peoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Weight; Participants with BMI < 95th percentile
Obese; Participants with BMI > or = 95th percentile

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiota Composition	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	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	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

Collaborators and Investigators

• Sponsor: University of Illinois College of Medicine at Peoria

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 31, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 1001223

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No