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NCT Number: NCT07752342

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

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.

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Key information

Conditions

Healthy Young Adults Anxiety Disorders Mental Disorders

Age range

15 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Comet Clinical

Cardiff, United Kingdom

Location contact

Charlotte Chadwick

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifidobacterium longum, 1714™

Dietary Supplement

1 capsule daily for 8 weeks

Primary outcomes

  1. Change From Baseline to Week 4 in PROMIS Pediatric Anxiety CAT T-Score

    Time frame: 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.

Secondary outcomes

  1. Change From Baseline in PROMIS Pediatric Anxiety CAT T-Score at Weeks 6 and 8

    Time frame: Baseline to 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.

  2. Change From Baseline in PROMIS Parent Proxy Anxiety CAT T-Score

    Time frame: Baseline to Weeks 4, 6 and 8.

    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.

  3. Change From Baseline in PROMIS Pediatric Cognitive Function CAT T-Score

    Time frame: Baseline to Weeks 4, 6 and 8.

    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.

  4. Change From Baseline in PROMIS Parent Proxy Cognitive Function CAT T-Score

    Time frame: Baseline to Weeks 4, 6 and 8.

    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.

  5. Change From Baseline in PROMIS Pediatric Depressive Symptoms CAT T-Score

    Time frame: Baseline to Weeks 4, 6 and 8.

    Mean change from baseline to Weeks 4, 6 and 8 in PROMIS Pediatric Depressive Symptoms CAT T-score, self-reported by adolescent participants. Higher scores indicate greater depressive symptom severity.

  6. Change From Baseline in PROMIS Parent Proxy Depressive Symptoms CAT T-Score

    Time frame: Baseline to Weeks 4, 6 and 8.

    Mean change from baseline to Weeks 4, 6 and 8 in PROMIS Parent Proxy Depressive Symptoms CAT T-score, as reported by parent participants. Higher scores indicate greater depressive symptom severity.

  7. Change From Baseline in PROMIS Pediatric Fatigue CAT T-Score

    Time frame: Baseline to Weeks 4, 6 and 8.

    Mean change from baseline to Weeks 4, 6 and 8 in PROMIS Pediatric Fatigue CAT T-score, self-reported by adolescent participants. Higher scores indicate greater fatigue.

  8. Change From Baseline in PROMIS Parent Proxy Fatigue CAT T-Score

    Time frame: Baseline to Weeks 4, 6 and 8.

    Mean change from baseline to Weeks 4, 6 and 8 in PROMIS Parent Proxy Fatigue CAT T-score, as reported by parent participants. Higher scores indicate greater fatigue.

  9. Change From Baseline in PROMIS Pediatric Peer Relationships CAT T-Score

    Time frame: Baseline to Weeks 4, 6 and 8.

    Mean change from baseline to Weeks 4, 6 and 8 in PROMIS Pediatric Peer Relationships CAT T-score, self-reported by adolescent participants. Higher scores indicate better peer relationships.

  10. Change From Baseline in PROMIS Parent Proxy Peer Relationships CAT T-Score

    Time frame: Baseline to Weeks 4, 6 and 8.

    Mean change from baseline to Weeks 4, 6 and 8 in PROMIS Parent Proxy Peer Relationships CAT T-score, as reported by parent participants. Higher scores indicate better peer relationships.

  11. Change From Baseline in PROMIS Pediatric Sleep Disturbance CAT T-Score

    Time frame: Baseline to Weeks 4, 6 and 8.

    Mean change from baseline to Weeks 4, 6 and 8 in PROMIS Pediatric Sleep Disturbance CAT T-score, self-reported by adolescent participants. Higher scores indicate greater sleep disturbance.

  12. Change From Baseline in PROMIS Parent Proxy Sleep Disturbance CAT T-Score

    Time frame: Baseline to Weeks 4, 6 and 8.

    Mean change from baseline to Weeks 4, 6 and 8 in PROMIS Parent Proxy Sleep Disturbance CAT T-score, as reported by parent participants. Higher scores indicate greater sleep disturbance.

  13. PROMIS Pediatric Anxiety Responder Rate at Weeks 4 and 8

    Time frame: Baseline to Weeks 4 and 8.

    Proportion of adolescent participants achieving a clinically meaningful improvement of at least 5 T-score points in PROMIS Pediatric Anxiety CAT T-score at Weeks 4 and 8 compared with baseline.

Other outcomes

  1. Change in Wearable-Derived Sleep Duration

    Time frame: Baseline through Week 8.

    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.

  2. Change in Wearable-Derived Stress Metrics

    Time frame: Baseline through Week 8.

    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.

  3. Change in Cognitive Performance Assessed by Verbal Paired Associates Learning (PAL)

    Time frame: Baseline to Weeks 4, 6 and 8.

    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.

  4. Study Product Compliance

    Time frame: Weekly during the 8-week intervention period.

    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.

  5. Study Product Acceptability Assessed by the Adolescent Experience Questionnaire (AEQ)

    Time frame: Week 8.

    Participant-reported assessment of study product and study participation experience using the Adolescent Experience Questionnaire.

  6. Study Product Acceptability Assessed by the Parent Experience Questionnaire (PEQ)

    Time frame: Week 8.

    Parent-reported assessment of study product and study participation experience using the Parent Experience Questionnaire.

  7. Incidence and Frequency of Adverse Events

    Time frame: Baseline through Week 8.

    Number and frequency of self-reported adverse events reported by adolescent participants or parent proxies during the study period.

  8. Completion Rate of Scheduled Study Assessments

    Time frame: Baseline through Week 8.

    Proportion of scheduled study questionnaires, cognitive assessments, wearable-derived assessments and compliance reports completed during the study period.

  9. Exploratory Subgroup Analyses of Wellbeing Outcomes

    Time frame: Baseline through Week 8.

    Exploratory assessment of changes in wellbeing outcomes according to participant characteristics including sex, age, ethnicity and baseline symptom severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Brian Krishnan

CONTACT

[email protected]

+44 (0)2921 203279

Charlotte Chadwick

CONTACT

[email protected]

+44 (0)2921 203279

Sponsors and collaborators

Lead sponsor

Novonesis

Industry

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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