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NCT07565883 · ClinicalTrials.gov registry record · NA
Adolescent Probiotics in Stressed Adolescents
A NA study, sponsored by University of Utah.
- Completed
- Registry status
- NA
- Development phase
- 104
- Enrollment target
NCT07565883: Completed NA study, sponsored by University of Utah.
NCT07565883 is a NA study that has completed, run by University of Utah. The registered enrollment target is 104 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07565883, a NA study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- NA
- Development phase
- 104 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- DIETARY_SUPPLEMENT placebo
- DIETARY_SUPPLEMENT Probiotics
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2022-05-03 |
| Est. Completion | 2024-11-25 |
| Phase | NA |
What the finished NCT07565883 record still lists
NCT07565883 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT07565883 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07565883 about?
NCT07565883 is a clinical study titled "Adolescent Probiotics in Stressed Adolescents". 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 str...
What is the current status of trial NCT07565883?
This trial is currently completed. It is a NA study. The enrollment target is 104 participants. The study started on 2022-05-03. Estimated completion is 2024-11-25.
What interventions are being tested in trial NCT07565883?
The interventions under investigation include: placebo (DIETARY_SUPPLEMENT), Probiotics (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07565883?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07565883's enrollment target sits among peer trials
104 836th of 2000 higher than 1,164 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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