Clinical Research Directory
Browse clinical research sites, groups, and studies.
Adolescent Probiotics in Stressed Adolescents
Sponsor: University of Utah
Summary
Stress is a normal human reaction to changes surrounding our reality, resulting in physical, emotional, and intellectual responses. Children and adolescents often experience high levels of stress. Age and gender may affect a child's ability to manage stress. Children and adolescents experiencing stress could be at an increased risk of poor cognitive, social, and emotional functioning. Probiotics are living microorganisms that could positively affect microbiota, support functions of numerous organs and systems, and overall human health. Most probiotics belong to the Lactobacillus genus. Probiotics can potentially support mental health, psychological function, and immune defenses. The purpose of this exploratory clinical trial is to investigate whether supplementation of the diets of adolescents experiencing moderate stress with the probiotic dietary supplement a blend of two probiotic Lactobacillus plantarum and one Lactobacillus brevis strains will support their emotions (e.g., psychological well-being, social relationship, stress levels, and self-efficacy), cognitive (e.g., attention, episodic and working memory) and immune functions (e.g., salivary IgA and salivary cytokine productions). This study is intended only to evaluate the dietary supplement's effect on the body's structure or function. Our investigation is not intended to mitigate, cure, treat, or prevent disease.
Official title: Analysis of Brain and Immune Functions in Adolescents Using Probiotics
Key Details
Gender
All
Age Range
12 Years - 20 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2022-05-03
Completion Date
2024-11-25
Last Updated
2026-05-04
Healthy Volunteers
Yes
Interventions
Probiotics
The participants started taking capsules the day after the first visit, after collecting the AM saliva sample, and continued taking them daily (preferably with a dinner meal) for 12 consecutive weeks. If the probiotic was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal
placebo
The participants started taking placebo capsules the day after the first visit, after collecting the AM saliva sample, and continued taking them daily (preferably with a dinner meal) for 12 consecutive weeks. If the probiotic was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal
Locations (2)
Division Clinical Pharmacology, SOM, University of Utah
Salt Lake City, Utah, United States
University of Utah, Pediatrics and Primary Childrens Hospital
Salt Lake City, Utah, United States