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COMPLETED
NCT07565883
NA

Adolescent Probiotics in Stressed Adolescents

Sponsor: University of Utah

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

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

DIETARY_SUPPLEMENT

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