Adolescent Probiotics in Stressed Adolescents

Completed · Not applicable · Has a placebo group

Conditions studied: Cognitive Ability, General, Immune System Function, Emotions

In brief

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.

Key facts

Study ID

NCT07565883

Run by

University of Utah

People needed

104

Starts

2022-05-03

Expected to finish

2024-11-25

Last updated by the study team

2026-05-04

Who can join

Age: 12 and older, up to 20. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants: Males and females
• Participants: 12-20 years old
• Participants with sustained moderate stress levels as determined by the Perceived Stress Scale (PSS), average score 14-26
• Participants with BMI percentile >5% and <97%
• Participants receiving or not receiving cognitive behavioral therapy.

You may not qualify if…

• Participants less than 12 years of age or over 20 years of age at enrollment.
• Participants with PSS average scores less than 14 and more than 26.
• Participants with BMI percentile <5% or >97%
• Participants receiving selective serotonin reuptake inhibitors (SSRIs).
• Participants who take any nutraceutical having an effect on stress anxiety within 1 month before subject screening.
• Participants who are female and report being pregnant.
• Participants receiving immunosuppressive therapy.
• Participants having immune deficiencies.
• Adverse reactions to any probiotic.

Where it is running

• 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

Full record on ClinicalTrials.gov

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