Probiotics and the Gut Microbiome in Obese Hispanic Youth
Stopped early · Not applicable · Has a placebo group
Conditions studied: Obesity, Abdominal, Adiposity
In brief
This study will recruit 40 obese Hispanic youth (12 - 18 years of age who are greater than or equal to Tanner stage 4) from hospitals, clinics, and community centers. Participants will be randomly assigned to 16 weeks of probiotics (3 packets/day of VSL#3) or matched placebo. The purpose of this study is to demonstrate through a proof-of-concept trial that probiotics have the potential to alter the gut microbiome and gut hormones.
Key facts
- Study ID
- NCT03115385
- Run by
- University of Southern California
- People needed
- 22
- Starts
- 2015-05-30
- Expected to finish
- 2016-04-11
- Last updated by the study team
- 2017-04-14
Who can join
Age: 12 and older, up to 18. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Inclusion Criteria:
- Obese (BMI percentile ≥95th for age and gender)
- Hispanic males and females who are 12-18 years of age and are ≥Tanner Stage 4.
You may not qualify if…
- Participants will be excluded from the study if any of the following apply:
- diagnosis of any disease that is known to influence insulin action and secretion (including type 1 and 2 diabetes);
- current or past involvement in any weight loss, exercise, or sports program in the six months prior to participation
- use of medication known to influence body composition or fat distribution (e.g. Cushing syndrome), insulin resistance, gut function, or lipid profiles;
- history of renal / liver disease or any disease affecting liver fibrosis and steatosis;
- diagnosis/current treatment for celiac, inflammatory bowel disease, Crohn's disease or other major GI issues;
- those who are immune compromised;
- pregnancy;
- current smoking (more than 1 cigarette in the past week), >200 cigarettes in lifetime, or use of other recreational drugs;
- alcohol consumption;
- other siblings in the study;
- physician diagnosis of major illness or eating disorder;
- physical/cognitive handicaps preventing participation;
- and recent antibiotic treatment (within the previous 30 days).
Where it is running
- University of Southern California — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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