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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Bifidobacterium longum, 1714™
  1 capsule daily for 8 weeks

Первичные конечные точки

• Change From Baseline to Week 4 in PROMIS Pediatric Anxiety CAT T-Score [Срок оценки: Baseline to week 4.]

Вторичные конечные точки (12)

• Change From Baseline in PROMIS Pediatric Anxiety CAT T-Score at Weeks 6 and 8 [Срок оценки: Baseline to Weeks 6 and 8.]
• Change From Baseline in PROMIS Parent Proxy Anxiety CAT T-Score [Срок оценки: Baseline to Weeks 4, 6 and 8.]
• Change From Baseline in PROMIS Pediatric Cognitive Function CAT T-Score [Срок оценки: Baseline to Weeks 4, 6 and 8.]
• Change From Baseline in PROMIS Parent Proxy Cognitive Function CAT T-Score [Срок оценки: Baseline to Weeks 4, 6 and 8.]
• Change From Baseline in PROMIS Pediatric Depressive Symptoms CAT T-Score [Срок оценки: Baseline to Weeks 4, 6 and 8.]
• Change From Baseline in PROMIS Parent Proxy Depressive Symptoms CAT T-Score [Срок оценки: Baseline to Weeks 4, 6 and 8.]
• Change From Baseline in PROMIS Pediatric Fatigue CAT T-Score [Срок оценки: Baseline to Weeks 4, 6 and 8.]
• Change From Baseline in PROMIS Parent Proxy Fatigue CAT T-Score [Срок оценки: Baseline to Weeks 4, 6 and 8.]
• Change From Baseline in PROMIS Pediatric Peer Relationships CAT T-Score [Срок оценки: Baseline to Weeks 4, 6 and 8.]
• Change From Baseline in PROMIS Parent Proxy Peer Relationships CAT T-Score [Срок оценки: Baseline to Weeks 4, 6 and 8.]
• Change From Baseline in PROMIS Pediatric Sleep Disturbance CAT T-Score [Срок оценки: Baseline to Weeks 4, 6 and 8.]
• Change From Baseline in PROMIS Parent Proxy Sleep Disturbance CAT T-Score [Срок оценки: Baseline to Weeks 4, 6 and 8.]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Великобритания · 1 центр

• Comet Clinical — Cardiff

Публикации

• 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. PMID 38355674
• Moloney 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. PMID 34589719
• Cryan 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 PMID 31460832
• Wang 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. PMID 30998517
• Allen 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. PMID 27801892

Идентификаторы

NCT: NCT07752342 · HHB-MH-25-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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