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

NCT ID: NCT03149601

Last Updated: 2019-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-07

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Childhood Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy Weight

Participants with BMI \< 95th percentile

No interventions assigned to this group

Obese

Participants with BMI \> or = 95th percentile

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois College of Medicine at Peoria

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Illinois College of Medicine at Peoria

Peoria, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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1001223

Identifier Type: -

Identifier Source: org_study_id

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