Exploring Wellbeing Outcomes in Adolescents Using Bifidobacterium Longum, 1714™: a Prospective Open-Label Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 4 in PROMIS Pediatric Anxiety CAT T-Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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
排除标准
- •(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)
研究组 & 干预措施
Bifidobacterium longum, 1714™
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.
干预措施: Bifidobacterium longum, 1714™ (Dietary Supplement)
结局指标
主要结局
Change From Baseline to Week 4 in PROMIS Pediatric Anxiety CAT T-Score
时间窗: 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.
次要结局
- Change From Baseline in PROMIS Pediatric Anxiety CAT T-Score at Weeks 6 and 8(Baseline to Weeks 6 and 8.)
- Change From Baseline in PROMIS Parent Proxy Anxiety CAT T-Score(Baseline to Weeks 4, 6 and 8.)
- Change From Baseline in PROMIS Pediatric Cognitive Function CAT T-Score(Baseline to Weeks 4, 6 and 8.)
- Change From Baseline in PROMIS Parent Proxy Cognitive Function CAT T-Score(Baseline to Weeks 4, 6 and 8.)
- Change From Baseline in PROMIS Pediatric Depressive Symptoms CAT T-Score(Baseline to Weeks 4, 6 and 8.)
- Change From Baseline in PROMIS Parent Proxy Depressive Symptoms CAT T-Score(Baseline to Weeks 4, 6 and 8.)
- Change From Baseline in PROMIS Pediatric Fatigue CAT T-Score(Baseline to Weeks 4, 6 and 8.)
- Change From Baseline in PROMIS Parent Proxy Fatigue CAT T-Score(Baseline to Weeks 4, 6 and 8.)
- Change From Baseline in PROMIS Pediatric Peer Relationships CAT T-Score(Baseline to Weeks 4, 6 and 8.)
- Change From Baseline in PROMIS Parent Proxy Peer Relationships CAT T-Score(Baseline to Weeks 4, 6 and 8.)
- Change From Baseline in PROMIS Pediatric Sleep Disturbance CAT T-Score(Baseline to Weeks 4, 6 and 8.)
- Change From Baseline in PROMIS Parent Proxy Sleep Disturbance CAT T-Score(Baseline to Weeks 4, 6 and 8.)
- PROMIS Pediatric Anxiety Responder Rate at Weeks 4 and 8(Baseline to Weeks 4 and 8.)