Exploring Wellbeing Outcomes in Adolescents Using Bifidobacterium Longum, 1714™: a Prospective Op… (NCT07752342) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Exploring Wellbeing Outcomes in Adolescents Using Bifidobacterium Longum, 1714™: a Prospective Open-Label Real-World Study
United Kingdom150 participantsStarted 2026-09
Plain-language summary
The purpose of this study is to evaluate changes in self-reported wellbeing outcomes in adolescents. Bifidobacterium longum, 1714™ has previously been associated with beneficial effects on stress-related outcomes, sleep quality, subjective wellbeing and aspects of cognitive performance, however evidence in adolescents is limited. This study will evaluate changes in outcomes related to anxiety, sleep, fatigue, cognitive function and other wellbeing outcomes following daily consumption of Bifidobacterium longum, 1714™ under real-world conditions.
Who can participate
Age range
15 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (Adolescents):
* Aged 15-17 years at the time of study screening
* Able and willing to provide informed consent or assent, with parental consent where applicable.
* Enrolled in school or college at the time of screening
* Participants must be able to read and understand English.
* Self-reporting mild-to-moderate feelings of anxiety (≥55 and ≤69 T-score - mild-to-moderate anxiety - on PROMIS Pediatric Anxiety CAT, as assessed during screening
* Owner of a personal smartphone which: (i) only they have access to, and (ii) has Apple AppStore or Android store access to the free-to-use Trialflare app.
* Willing to:
* Consume the study product daily for the duration of the study
* Setup a Garmin account by email
* Wear a provided wearable device during the study period
* Complete study assessments digitally
Exclusion Criteria (Adolescents):
* Pregnant, breastfeeding, or planning pregnancy during the study period
* Known allergy or intolerance to any component of the study product
* Presence of a significant medical or psychiatric condition that may:
* Pose a safety risk, or
* Confound interpretation of study outcomes, as judged by the Investigator
* Current diagnosis of:
* Bipolar disorder
* Clinical anxiety disorder or depression
* Current or recent (within the last 3 months) use of:
* Antidepressants, anxiolytics, or antibiotics
* Other probiotic products
* Supplements intended to affect mood, sleep, stress, or anxiety
* N.B. Use of such items may still be co…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline to Week 4 in PROMIS Pediatric Anxiety CAT T-Score