NCT06258135已完成不适用
At Home Placebo-controlled 8-week GOS Intervention on Emotion Behaviour and Cognition in Children (Age 6-14 Years).
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Changes in emotion processing.
研究概览
简要总结
This study aims to investigate how GOS food supplement influences the gut-microbiome-brain axis to improve emotion regulation skills and cognition in a sample of children and adolescents (aged 6-14 years).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Typically developing, healthy male or female aged 6-14 years
- •Access to home laptop/ personal computer
排除标准
- •Current clinical levels of anxiety and/or co-morbid psychological diagnoses
- •Neuro/developmental disorders
- •Gastro-intestinal problems or disease
- •Restrictive diets (e.g., lactose intolerance, gluten free)
研究组 & 干预措施
Treatment
Active Comparator
干预措施: Galacto-oligosaccharide (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
Changes in emotion processing.
时间窗: End of treatment (4 weeks), Follow up (8 weeks).
Performance on behavioural task: emotional dot-probe task.
Changes in trait anxiety.
时间窗: End of treatment (4 weeks), Follow up (8 weeks).
Self report instrument: state-trait anxiety measure for children (STAIC) - Trait scale.
次要结局
- Changes in depression.(End of treatment (4 weeks), Follow up (8 weeks).)
- Changes in nutrient intake(End of treatment (4 weeks), Follow up (8 weeks).)
- Changes in attention networks.(End of treatment (4 weeks), Follow up (8 weeks).)
研究者
研究点 (1)
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