Adolescent Probiotics in Stressed Adolescents

NCT07565883 | Completed

• 1 other identifier: 20211028
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

adolescent; moderate stress; probiotics; cognition; emotional status; immune functions

Outcome Measures

Primary Outcomes (1)

• Emotinal status and cognitive functions of participants

  The NIH Toolbox was used to assess participants' emotional and cognitive functions. The Emotion Domain consisted of instruments evaluating psychological well-being, social relationships, stress, self-efficacy, and negative affect. Additionally, PROMIS CAT Emotional Support, Psychological Stress Experiences, and Sleep Disturbance tests were administered. The Cognition Domain test consisted of attention, episodic and working memories, language, and processing speed.

  From enrollment (week 0), 8 weeks and 12 weeks (end of study)

Secondary Outcomes (2)

• Changes in the immune functions of participants

  From enrollment (week 0), 8 weeks and 12 weeks (end of study)

• Evaluation of AM and PM cortisol levels

  From enrollment (week 0), 8 weeks and 12 weeks (end of study)

Study Arms (2)

Probiotics supplement

EXPERIMENTAL

Participants received the probiotics blend containing two Lactobacillus plantarum and one Lactobacillus brevis strains for 12 weeks. The probiotic blend contained 2 billion CFU bacteria. Stains are present in the mixture at a ratio of 2:1:1. Participants were taking them daily with meals, (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: Probiotics

Placebo cohort

PLACEBO COMPARATOR

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 capsule was not taken during dinner, it should be taken within 2 hours after dinner or with the next meal

Dietary Supplement: placebo

Interventions

Probiotics DIETARY_SUPPLEMENT

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

Probiotics supplement

placebo DIETARY_SUPPLEMENT

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

Placebo cohort

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• University of Utah: lead
• Kaneka Americas Holding Inc.: collaborator

Study Sites (2)

Division Clinical Pharmacology, SOM, University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Utah, Pediatrics and Primary Childrens Hospital

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• 1. Steenbergen, L., Sellaro, R., van Hemert, S., Bosch, J. A., and Colzato, L. S. (2015) A randomized controlled trial to test the effect of multispecies probiotics on cognitive reactivity to sad mood. Brain Behav Immun 48, 258-264 2. Chong, H. X., Yusoff, N. A. A., Hor, Y. Y., Lew, L. C., Jaafar, M. H., Choi, S. B., Yusoff, M. S. B., Wahid, N., Abdullah, M., Zakaria, N., Ong, K. L., Park, Y. H., and Liong, M. T. (2019) Lactobacillus plantarum DR7 alleviates stress and anxiety in adults: a randomised, double-blind, placebo-controlled study. Benef Microbes 10, 355-373 3. Quagliato, L. A., and Nardi, A. E. (2018) Cytokine alterations in panic disorder: A systematic review. J Affect Disord 228, 91-96

  BACKGROUND

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 4, 2026
• Study Start: May 3, 2022
• Primary Completion: July 22, 2024
• Study Completion: November 25, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)