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.
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.
Pregnant, breastfeeding, or planning pregnancy during the study period
Known allergy or intolerance to any component of the study product
Pose a safety risk, or
Confound interpretation of study outcomes, as judged by the Investigator
Single group
Bifidobacterium longum, 1714™
Dietary supplement1 capsule daily for 8 weeks
Change From Baseline to Week 4 in PROMIS Pediatric Anxiety CAT T-Score
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.
Change From Baseline in PROMIS Pediatric Anxiety CAT T-Score at Weeks 6 and 8
Mean change from baseline to Weeks 6 and 8 in PROMIS Pediatric Anxiety Computer Adaptive Test (CAT) T-score, self-reported by adolescent participants. Higher T-scores indicate greater anxiety symptom severity.
Change From Baseline in PROMIS Parent Proxy Anxiety CAT T-Score
Mean change from baseline to Weeks 4, 6 and 8 in PROMIS Parent Proxy Anxiety CAT T-score, as reported by parent participants. Higher T-scores indicate greater anxiety symptom severity.
Change From Baseline in PROMIS Pediatric Cognitive Function CAT T-Score
Mean change from baseline to Weeks 4, 6 and 8 in PROMIS Pediatric Cognitive Function CAT T-score, self-reported by adolescent participants. Higher scores indicate better cognitive functioning.
Change From Baseline in PROMIS Parent Proxy Cognitive Function CAT T-Score
Mean change from baseline to Weeks 4, 6 and 8 in PROMIS Parent Proxy Cognitive Function CAT T-score, as reported by parent participants. Higher scores indicate better cognitive functioning.
Change in Wearable-Derived Sleep Duration
Change over time in sleep duration derived from Garmin wearable device data collected throughout the study period. Sleep data will be collected passively and continuously during the run-in and intervention periods.
Change in Wearable-Derived Stress Metrics
Change over time in stress-related metrics derived from wearable device data collected throughout the study period. Stress measures will be collected passively and continuously during the run-in and intervention periods.
Change in Cognitive Performance Assessed by Verbal Paired Associates Learning (PAL)
Change from baseline in cognitive performance assessed using the electronic verbal Paired Associates Learning (PAL) task. The assessment is exploratory and not intended for diagnostic use.
Study Product Compliance
Self-reported compliance with study product consumption, assessed as the number of days per week participants report taking the study product during the intervention period.
This trial is not recruiting at the moment. You can still explore other options:
