ADHD, Gut Problems and Synbiotic
2026年7月16日 更新者：Super Synbiotics AB
Gut-Brain Study: ADHD, Gastrointestinal Problems and Synbiotic Cap
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.
研究概览
研究类型
介入性
注册 (估计的)
174
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ludvig Ekelund
- 电话号码：+46 8 6601660
- 邮箱：forskning@supersynbiotics.se
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Has consumed antibiotics within the previous 6 weeks
- Has a serious disease that requires treatment and/or leads to a weakened immune system
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Synbiotic Cap Gut-Brain
Capsules containing the synbiotic product being evaluated.
The product consists of a combination of probiotic bacteria (at a total dose of 15 x 10^9 CFU/2 capsule), dietary fibers (120 mg), calcium and vitamin B. The participants will be instructed to consume 2 capsules once every day, during a period of 12 weeks.
|
Capsules (2 capsules to be ingested once daily during 12 weeks)
|
|
安慰剂比较：Placebo
Capsules containing placebo consisting of maltodextrin.
The capsules look, smell and taste the same as the capsules for the experimental product.
The participants will be instructed to consume 2 capsules once every day, during a period of 12 weeks.
|
Capsules (2 capsules to be ingested once daily during 12 weeks)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in the total score of Difficulties Regulation Scale 16 (DERS-16) after 12 weeks of intervention.
大体时间：Change from baseline to 12 weeks
|
All subscales are included in the total score of DERS-16 (Clarity, Goals, Impulse, Strategies and Nonacceptance)
|
Change from baseline to 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in total score for gastrointestinal symptoms (based on a questionnaire) after 12 weeks of intervention.
大体时间：Change from baseline to 12 weeks
|
The questionnaire consists of a 5-point scale to evaluate the frequency of symptoms such as flatulence, bloating, loose/hard stools, gut pain, feeling sick.
|
Change from baseline to 12 weeks
|
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Change from baseline in total score of ASRS v1.1 after 12 weeks of intervention
大体时间：Change from baseline to 12 weeks
|
The adult ADHD self-report scale consists of 18 items.
Change from baseline in the total score for these items will be measured.
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Change from baseline to 12 weeks
|
|
Change from baseline in the DERS-16 subscale scores after 12 weeks of intervention.
大体时间：Change from baseline after 12 weeks.
|
The score for each of the DERS-16 subscales (Clarity, Goals, Impulse, Strategies and Nonacceptance) will be analyzed separately
|
Change from baseline after 12 weeks.
|
|
Change from baseline in the frequency of individual gastrointestinal symptoms after 12 weeks of intervention.
大体时间：Change from baseline to 12 weeks
|
The individual gastrointestinal symptoms include flatulence, bloating, loose/hard stools, gut pain, feeling sick.
|
Change from baseline to 12 weeks
|
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Change from baseline in the score of individual ASRS v1.1 items after 12 weeks of intervention.
大体时间：Change from baseline to 12 weeks.
|
The 18 ASRS items will be assessed separately.
|
Change from baseline to 12 weeks.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年10月31日
研究完成 (估计的)
2027年12月1日
研究注册日期
首次提交
2026年7月16日
首先提交符合 QC 标准的
2026年7月16日
首次发布 (实际的)
2026年7月21日
研究记录更新
最后更新发布 (实际的)
2026年7月21日
上次提交的符合 QC 标准的更新
2026年7月16日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.