Exploring Wellbeing Outcomes in Adolescents Using Bifidobacterium Longum, 1714™: a Prospective Open-Label Real-World Study

N/ANot Yet RecruitingNCT07752342

Novonesis150 enrolled

Overview

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.

Adolescence is a developmental period associated with increased vulnerability to feelings of anxiety, stress and sleep disturbance. Growing evidence suggests that the gut microbiota may influence emotional and cognitive processes through the gut-brain axis. Bifidobacterium longum, 1714™ has previously been investigated in adult populations and has been associated with improvements in stress-related outcomes, sleep quality, wellbeing and aspects of cognitive performance. However, evidence in adolescent populations remains limited. The purpose of this study is to evaluate changes in wellbeing outcomes following daily consumption of a dietary supplement containing Bifidobacterium longum, 1714™ in adolescents under real-world conditions. Adolescents aged 15-17 years who self-report feelings of mild-to-moderate anxiety will participate in a prospective, open-label, single-arm study conducted remotely in the United Kingdom. Participants will consume one capsule containing 1 × 10⁹ CFU of Bifidobacterium longum, 1714™ daily for 8 weeks following a 2-week run-in period. Outcomes will be assessed using PROMIS Pediatric questionnaires, parent proxy-reported measures, wearable-derived sleep and stress metrics, cognitive assessments and safety monitoring procedures. The primary objective is to evaluate change from baseline to Week 8 in PROMIS Pediatric Anxiety T-score. Secondary and exploratory objectives include assessment of sleep, fatigue, depressive symptoms, peer relationships, cognitive function, wearable-derived outcomes, study compliance and participant experience.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Eligibility

Sex: ALLMin age: 15 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline to week 4.

Secondary Outcomes

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.

Time frame: Baseline to Weeks 6 and 8.

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.