Host-Microbe Interactomics, Wageningen University and Research, Wageningen, The Netherlands.
Medical Centre Kinderplein, Rotterdam, The Netherlands.
BMJ Open. 2019 Nov 5;9(11):e029422. doi: 10.1136/bmjopen-2019-029422.
Attention deficit hyperactivity disorder (ADHD) is the most common childhood behavioural disorder, causing significant impediment to a child's development. It is a complex disorder with numerous contributing (epi)genetic and environmental factors. Currently, treatment consists of behavioural and pharmacological therapy. However, ADHD medication is associated with several side effects, and concerns about long-term effects and efficacy exist. Therefore, there is considerable interest in the development of alternative treatment options. Double-blind research investigating the effects of a few-foods diet (FFD) has demonstrated a significant decrease in ADHD symptoms following an FFD. However, an FFD requires a considerable effort of both child and parents, limiting its applicability as a general ADHD treatment. To make FFD intervention less challenging or potentially obsolete, we need to understand how, and in which children, an FFD affects ADHD behaviour and, consequently, the child's well-being. We hypothesise that an FFD affects brain function, and that the nutritional impact on ADHD is effectuated by a complex interplay between the microbiota, gut and brain, that is, the microbiota-gut-brain axis.
The Biomarker Research in ADHD: the Impact of Nutrition (BRAIN) study is an open-label trial with researchers blinded to changes in ADHD symptoms during sample processing and initial data analyses.
The Medical Research and Ethics Committee of Wageningen University has approved this study (NL63851.081.17, application 17/24). Results will be disseminated through peer-reviewed journal publications, conference presentations, (social) media and the BRAIN study website. A summary of the findings will be provided to the participants.
NCT03440346.
Collection of primary outcome data started in March 2018 and will be ongoing until 100 children have participated in the study. Sample data analysis will start after all samples have been collected.
注意力缺陷多动障碍（ADHD）是最常见的儿童行为障碍，严重阻碍了儿童的发展。它是一种复杂的疾病，有许多遗传和环境因素。目前的治疗方法包括行为和药物治疗。然而，ADHD 药物治疗存在许多副作用，并且对长期效果和疗效存在担忧。因此，人们对开发替代治疗方案有很大的兴趣。双盲研究调查了一种限食疗法（FFD）的效果，结果表明，FFD 可显著降低 ADHD 症状。然而，FFD 需要孩子和家长付出大量努力，限制了其作为一般 ADHD 治疗的适用性。为了减少 FFD 干预的难度或使其变得不必要，我们需要了解 FFD 如何影响 ADHD 行为，以及哪些儿童会受到影响，从而影响儿童的福祉。我们假设 FFD 会影响大脑功能，而 ADHD 的营养影响是通过微生物群、肠道和大脑之间的复杂相互作用实现的，即微生物群-肠道-大脑轴。
ADHD 的生物标志物研究：营养的影响（BRAIN）研究是一项开放标签试验，研究人员在样本处理和初步数据分析过程中对 ADHD 症状的变化保持盲态。
瓦赫宁根大学医学研究和伦理委员会已批准该研究（NL63851.081.17，申请 17/24）。研究结果将通过同行评议的期刊出版物、会议演讲、（社交媒体）和 BRAIN 研究网站进行传播。研究结果将提供给参与者摘要。
NCT03440346.
主要结果数据的收集于 2018 年 3 月开始，预计将持续到 100 名儿童参与研究。样本数据分析将在所有样本收集完成后开始。
