NCT07717359尚未招募不适用
Gut-Brain Study: ADHD, Gastrointestinal Problems and Synbiotic Cap
Super Synbiotics AB0 个研究点目标入组 174 人开始时间: 2026年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 主要终点
- Change from baseline in the total score of Difficulties Regulation Scale 16 (DERS-16) after 12 weeks of intervention.
研究概览
简要总结
The scope of this study is to evaluate the impact of a synbiotic product (a combination of probiotic bacteria and prebiotics) on symptoms reported by participants with ADHD. The main focus is to study the efficacy of the synbiotic product as compared to a placebo in improving emotion regulation and gut-health associated symptoms in adults with ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADHD-diagnosis
- •Self-described gastrointestinal problems
- •Has not previously consumed Synbiotics
- •Be prepared to avoid supplements with lactic acid bacteria, calcium and vitamin B6, B9, and B12, starting from washout
排除标准
- •Has consumed antibiotics within the previous 6 weeks
- •Has a serious disease that requires treatment and/or leads to a weakened immune system
结局指标
主要结局
Change from baseline in the total score of Difficulties Regulation Scale 16 (DERS-16) after 12 weeks of intervention.
时间窗: Change from baseline to 12 weeks
All subscales are included in the total score of DERS-16 (Clarity, Goals, Impulse, Strategies and Nonacceptance)
次要结局
- Change from baseline in total score for gastrointestinal symptoms (based on a questionnaire) after 12 weeks of intervention.(Change from baseline to 12 weeks)
- Change from baseline in total score of ASRS v1.1 after 12 weeks of intervention(Change from baseline to 12 weeks)
- Change from baseline in the DERS-16 subscale scores after 12 weeks of intervention.(Change from baseline after 12 weeks.)
- Change from baseline in the frequency of individual gastrointestinal symptoms after 12 weeks of intervention.(Change from baseline to 12 weeks)
- Change from baseline in the score of individual ASRS v1.1 items after 12 weeks of intervention.(Change from baseline to 12 weeks.)
研究者
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