Childhood Obesity Microbiome Study
Completed · Not applicable
Conditions studied: Pediatric Obesity
In brief
The purpose of this study is to measure the effectiveness of a microbiome diet using direct food provision on dietary quality and microbiome composition among children with obesity. This study proposes a pilot randomized, controlled clinical trial in children of a dietary intervention informed by microbiome science.
Key facts
- Study ID
- NCT04770311
- Run by
- Duke University
- People needed
- 33
- Starts
- 2021-04-09
- Expected to finish
- 2021-11-20
- Last updated by the study team
- 2022-04-15
Who can join
Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Child aged 6 - 11 years (not yet aged 12)
- Child with BMI ≥ 95th percentile
- Parents are willing to accept home deliveries and have the ability to be home at the time and day that is most convenient for them to receive the groceries; or, have transportation available to go and pick up groceries at a time and date that is most convenient for them at a Walmart location.
You may not qualify if…
- Does the child have a current diagnosis of obesity due to an underlying condition such as hypothyroidism, Cushing's disease, or known genetic condition?
- Is the child currently taking any weight-loss medication (steroids, anti-psychotics, anti-depressants)
- Has the child started a stimulant medication in the past 3 months? (stimulants include, among others, Ritalin, Adderall, concerta, focalin, vyvanse).
- Is the child currently taking, or has taken in the past 4 weeks, an antibiotic?
- Is the child currently taking, or plans to take in the next 4 weeks, a weight loss medication?
- Is the patient on a pharmacotherapy or weight loss surgery track in Healthy Lifestyless?
- Has the patient lost more than 5% of their body weight in the preceding 6 months?
Where it is running
- Duke Healthy Lifestyles Roxboro Street — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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