Bifidobacterium longum, 1714™: 1 capsule daily for 8 weeks
Study 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.
Eligibility
Sex
ALL
Min age
15 Years
Max age
17 Years
Healthy volunteers
Accepted
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 considered via an adaptive approach, reducing the time to last use to 1 month instead of 3 months
* Participation in another clinical or nutritional study that could interfere with this study
* Current use of cognitive behavioural therapy or counselling to manage anxiety- or low mood-like symptoms
* Considered by the PI to be a poor candidate for compliance or data submission
Inclusion Criteria (Parents)
* Legal guardian of an enrolled A-Participant
* Living in the same household as the A-Participant
* Able to provide informed consent
* Owner of a personal smartphone compatible with the study application
Exclusion Criteria (Parents)
* None
Primary outcome measure(s)
Change From Baseline to Week 4 in PROMIS Pediatric Anxiety CAT T-Score — Baseline to week 4. Mean change from baseline to Week 4 in PROMIS Pediatric Anxiety Computer Adaptive Test (CAT) T-score, self-reported by adolescent participants. PROMIS Anxiety is a standardized T-score measure, with higher scores indicating greater anxiety symptom severity.
Trial sites (1)
Facility
City
Region
Status
Comet Clinical
Cardiff
United Kingdom
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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