Healthy Young AdultsNCT07752342
Exploring Wellbeing Outcomes in Adolescents Using Bifidobacterium Longum, 1714™
A study testing Bifidobacterium longum, 1714™ in people with Healthy Young Adults, run by Novonesis at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- Bifidobacterium longum, 1714™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2026to Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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
- 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
Who cannot join
- 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:
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- 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
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Comet Clinical
Cardiff
Charlotte Chadwick, studyZT@cometclinical.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Healthy Young Adults
- Being tested
- Bifidobacterium longum, 1714™
- Keywords
- Probiotic, Anxiety, Gut-brain axis, Psychobiotic, Adolescent wellbeing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium longum, 1714™Dietary supplement
1 capsule daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium longum, 1714™ | Experimental | 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. Receives: Dietary Supplement: Bifidobacterium longum, 1714™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to week 4.
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Weeks 4, 6 and 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy Young AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, open-label study in which adolescents aged 15-17 years will consume a dietary supplement containing Bifidobacterium longum, 1714™ once daily for 8 weeks. Participants will be followed remotely using electronic participant-reported outcomes, parent proxy assessments, wearable-derived measures, cognitive assessments and safety monitoring. There is no randomisation, blinding or control group.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novonesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Webberley, PhD, Study director, NovonesisCharlotte Chadwick, Principal investigator, Comet Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752342
- Sponsor's protocol ID
- HHB-MH-25-02
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patterson E, Tan HTT, Groeger D, Andrews M, Buckley M, Murphy EF, Groeger JA. Bifidobacterium longum 1714 improves sleep quality and aspects of well-being in healthy adults: a randomized, double-blind, placebo-controlled clinical trial. Sci Rep. 2024 Feb 14;14(1):3725. doi: 10.1038/s41598-024-53810-w.
PubMed 38355674Moloney GM, Long-Smith CM, Murphy A, Dorland D, Hojabri SF, Ramirez LO, Marin DC, Bastiaanssen TFS, Cusack AM, Berding K, Fouhy F, Allen AP, Stanton C, Clarke G, Dinan TG, Cryan JF. Improvements in sleep indices during exam stress due to consumption of a Bifidobacterium longum. Brain Behav Immun Health. 2020 Nov 13;10:100174. doi: 10.1016/j.bbih.2020.100174. eCollection 2021 Jan.
PubMed 34589719Cryan JF, O'Riordan KJ, Cowan CSM, Sandhu KV, Bastiaanssen TFS, Boehme M, Codagnone MG, Cussotto S, Fulling C, Golubeva AV, Guzzetta KE, Jaggar M, Long-Smith CM, Lyte JM, Martin JA, Molinero-Perez A, Moloney G, Morelli E, Morillas E, O'Connor R, Cruz-Pereira JS, Peterson VL, Rea K, Ritz NL, Sherwin E, Spichak S, Teichman EM, van de Wouw M, Ventura-Silva AP, Wallace-Fitzsimons SE, Hyland N, Clarke G, Dinan TG. The Microbiota-Gut-Brain Axis. Physiol Rev. 2019 Oct 1;99(4):1877-2013. doi: 10.1152/physrev.00018.2018.
PubMed 31460832Wang H, Braun C, Murphy EF, Enck P. Bifidobacterium longum 1714 Strain Modulates Brain Activity of Healthy Volunteers During Social Stress. Am J Gastroenterol. 2019 Jul;114(7):1152-1162. doi: 10.14309/ajg.0000000000000203.
PubMed 30998517Allen AP, Hutch W, Borre YE, Kennedy PJ, Temko A, Boylan G, Murphy E, Cryan JF, Dinan TG, Clarke G. Bifidobacterium longum 1714 as a translational psychobiotic: modulation of stress, electrophysiology and neurocognition in healthy volunteers. Transl Psychiatry. 2016 Nov 1;6(11):e939. doi: 10.1038/tp.2016.191.
PubMed 27801892