An interventional study of Bifidobacterium longum, 1714™ in Healthy Young Adults, sponsored by Novonesis. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 15 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Novonesis · Not applicable, Interventional, and Other
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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Novonesis is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Inclusion Criteria (Adolescents):
Exclusion Criteria (Adolescents):
Inclusion Criteria (Parents)
Exclusion Criteria (Parents)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One capsule containing Bifidobacterium longum, 1714™ (1 × 10⁹ CFU per capsule). The dietary supplement also contains thiamine (vitamin B1), riboflavin (vitamin B2), niacin (vitamin B3), vitamin B6, folic acid, vitamin B12, biotin and pantothenic acid, each provided at approximately 100% of the daily Nutrient Reference Value. Additional ingredients include corn starch, hydroxypropyl methylcellulose (capsule shell) and magnesium stearate.
Dietary Supplement: Bifidobacterium longum, 1714™
1 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.
Time frame: Baseline to week 4.
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.
Time frame: Baseline to Weeks 4, 6 and 8.
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.
Time frame: Baseline to Weeks 4, 6 and 8.
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.
Time frame: Baseline to Weeks 4, 6 and 8.
Change From Baseline in PROMIS Pediatric Depressive Symptoms CAT T-Score
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.
Time frame: Baseline to Weeks 4, 6 and 8.
Change From Baseline in PROMIS Parent Proxy Depressive Symptoms CAT T-Score
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.
Time frame: Baseline to Weeks 4, 6 and 8.
Change From Baseline in PROMIS Pediatric Fatigue CAT T-Score
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.
Time frame: Baseline to Weeks 4, 6 and 8.
Change From Baseline in PROMIS Parent Proxy Fatigue CAT T-Score
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.
Time frame: Baseline to Weeks 4, 6 and 8.
Change From Baseline in PROMIS Pediatric Peer Relationships CAT T-Score
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.
Time frame: Baseline to Weeks 4, 6 and 8.
Change From Baseline in PROMIS Parent Proxy Peer Relationships CAT T-Score
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.
Time frame: Baseline to Weeks 4, 6 and 8.
Change From Baseline in PROMIS Pediatric Sleep Disturbance CAT T-Score
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.
Time frame: Baseline to Weeks 4, 6 and 8.
Change From Baseline in PROMIS Parent Proxy Sleep Disturbance CAT T-Score
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.
Time frame: Baseline to Weeks 4, 6 and 8.
PROMIS Pediatric Anxiety Responder Rate at Weeks 4, 6 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, 6 and 8 compared with baseline.
Time frame: Baseline to Weeks 4, 6 and 8.
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.
Time frame: Baseline through Week 8.
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.
Time frame: Baseline through Week 8.
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.
Time frame: Baseline to Weeks 4, 6 and 8.
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.
Time frame: Weekly during the 8-week intervention period.
Study Product Acceptability Assessed by the Adolescent Experience Questionnaire (AEQ)
Participant-reported assessment of study product and study participation experience using the Adolescent Experience Questionnaire.
Time frame: Week 8.
Study Product Acceptability Assessed by the Parent Experience Questionnaire (PEQ)
Parent-reported assessment of study product and study participation experience using the Parent Experience Questionnaire.
Time frame: Week 8.
Incidence and Frequency of Adverse Events
Number and frequency of self-reported adverse events reported by adolescent participants or parent proxies during the study period.
Time frame: Baseline through Week 8.
Completion Rate of Scheduled Study Assessments
Proportion of scheduled study questionnaires, cognitive assessments, wearable-derived assessments and compliance reports completed during the study period.
Time frame: Baseline through Week 8.
Exploratory Subgroup Analyses of Wellbeing Outcomes
Exploratory assessment of changes in wellbeing outcomes according to participant characteristics including sex, age, ethnicity and baseline symptom severity.
Time frame: Baseline through Week 8.
Plan to share: No
Start is estimated for Sep 2026; primary completion for Apr 2027, 7 months later.
Of 102 industry-sponsored interventional studies with no phase under Anxiety Disorders, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 7 months is above that.
Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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