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Adolescent Probiotics in Stressed Adolescents

NCT07565883 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Cognitive Ability, General
  • Immune System Function
  • Emotions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2024-07-22
Completion
2024-11-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07565883 on ClinicalTrials.gov