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Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children

2026年6月22日 更新者：Khyber Medical University Peshawar

Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children: A Randomized Controlled Trial

This randomized controlled trial will evaluate the effectiveness of neuroplasticity-targeted supplements on neuroinflammatory markers and ADHD symptoms in children aged 6 to 12 years diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Participants will be randomly assigned to one of four groups: gut-targeted supplements (prebiotics and probiotics), brain-targeted supplements (omega-3 fatty acids and vitamin B1), combined supplementation, or placebo. The intervention period will last 12 weeks. Primary outcomes include changes in ADHD symptom severity and clinical scores using validated rating scales. Secondary outcomes include changes in biomarkers of neuroinflammation and neuroplasticity, including IL-6, TNF-alpha, BDNF, short-chain fatty acids, and Claudin-5.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity. Emerging evidence suggests that neuroinflammation, altered gut microbiota, and impaired neuroplasticity may contribute to ADHD pathophysiology. Nutritional interventions that target these mechanisms may provide additional therapeutic benefit.

This study is a randomized, placebo-controlled, parallel-group clinical trial designed to investigate whether supplementation with prebiotics, probiotics, omega-3 fatty acids, and vitamin B1 can improve ADHD symptoms and related biological markers in children. Sixty-eight participants aged 6 to 12 years with DSM-5 confirmed ADHD will be enrolled and randomly assigned in equal numbers to one of four intervention groups: (1) prebiotics plus probiotics, (2) omega-3 fatty acids plus vitamin B1, (3) combined supplementation, or (4) placebo.

The intervention duration will be 12 weeks. ADHD symptoms and behavioral scores will be assessed at baseline and after treatment using validated rating scales, including Conners 3 and Vanderbilt ADHD forms. Blood samples will be collected at baseline and week 12 for measurement of inflammatory and neuroplasticity biomarkers, including interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), brain-derived neurotrophic factor (BDNF), short-chain fatty acids (SCFA), Claudin-5, and complete blood count parameters.

The primary objective is to determine the effect of supplementation on ADHD symptom scores. Secondary objectives include comparison of treatment groups for biomarker changes and evaluation of associations between biological markers and clinical outcomes. Results may help identify safe adjunctive nutritional strategies for children with ADHD.

研究类型

介入性

注册 (估计的)

68

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

研究联系人备份

学习地点

  • 巴基斯坦
    • KPK
      • Peshawar、KPK、巴基斯坦、25000
        • 招聘中
        • Khyber Teaching Hospital
        • 接触：
          • Dr Dur e
        • 接触：
          • Dr Inayat Khan

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

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • DSM-5 confirmed ADHD diagnosis
  • Age 6-12 years
  • Medication-free or on stable stimulant medication (≥1 month)

Exclusion Criteria:

  • Antibiotic use in last 4 weeks
  • Gastrointestinal disorders
  • Neurological comorbidities (e.g., epilepsy)
  • Severe food allergies

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：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Gut-Targeted Supplements Group
Participants will receive prebiotics (inulin 6 g/day) and probiotics (Acidophilus Bifidus 2 × 10^11 CFU/day orally) for 12 weeks.
膳食补充剂：Inulin
Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
其他名称：
  • Fructan prebiotic
膳食补充剂：Probiotic
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
其他名称：
  • Acidophilus Bifidus
实验性的：Neuroplasticity-Targeted Supplements Group
Participants will receive omega-3 fatty acids containing EPA 650 mg and DHA 540 mg daily, plus vitamin B1 (thiamine 10 mg/day orally) for 12 weeks.
膳食补充剂：Omega-3 Fatty Acids
Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
其他名称：
  • Fish Oil, EPA, DHA
膳食补充剂：Thiamine
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
其他名称：
  • 维生素B1
实验性的：Combined Supplements Group
Participants will receive prebiotics (inulin 6 g/day), probiotics (Acidophilus Bifidus 2 × 10^11 CFU/day), omega-3 fatty acids containing EPA 650 mg and DHA 540 mg daily, and vitamin B1 (thiamine 10 mg/day orally) for 12 weeks.
膳食补充剂：Inulin
Participants will receive inulin powder 6 grams orally once daily for 12 weeks as a prebiotic supplement intended to support beneficial gut microbiota.
其他名称：
  • Fructan prebiotic
膳食补充剂：Probiotic
Participants will receive a probiotic supplement containing Acidophilus Bifidus 2 × 10^11 CFU orally once daily for 12 weeks.
其他名称：
  • Acidophilus Bifidus
膳食补充剂：Omega-3 Fatty Acids
Participants will receive omega-3 fatty acid supplementation containing EPA 650 mg and DHA 540 mg orally once daily for 12 weeks.
其他名称：
  • Fish Oil, EPA, DHA
膳食补充剂：Thiamine
Participants will receive thiamine (vitamin B1) 10 mg orally once daily for 12 weeks.
其他名称：
  • 维生素B1
安慰剂比较：Placebo Group
Participants will receive matching placebo supplements orally for 12 weeks.
其他：Placebo
Participants will receive matching placebo supplementation orally once daily for 12 weeks.
其他名称：
  • 匹配安慰剂

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
Parent and Teacher ADHD Rating
大体时间：Baseline and Week 12

Change in Attention-Deficit/Hyperactivity Disorder (ADHD) symptom severity measured using the Conners 3 Parent and Teacher ADHD Rating Scales. The Conners 3 assesses inattention, hyperactivity/impulsivity, executive functioning, learning problems, aggression, and peer relations. Raw scores are converted to T-scores, with higher scores indicating greater symptom severity and functional impairment.

Scale Information:

T-score range: approximately 40-90 Higher scores indicate worse ADHD symptoms.
Baseline and Week 12
Neuroinflammation Markers (IL-6, TNF-α)
大体时间：Baseline and Week 12
Change in serum levels of pro-inflammatory cytokines interleukin-6 and tumor necrosis factor-alpha measured by ELISA
Baseline and Week 12
Neuroplasticity Markers (BDNF, Claudin-5)
大体时间：Baseline and Week 12
Change in brain-derived neurotrophic factor (BDNF) and blood-brain barrier tight junction protein claudin-5 measured by ELISA
Baseline and Week 12
Short-Chain Fatty Acids (SCFA)
大体时间：Baseline and Week 12
Change in gut microbiota-derived metabolites (e.g., butyrate) measured by ELISA
Baseline and Week 12
Complete Blood Count (CBC)
大体时间：Baseline and Week 12
Change in blood cell counts (e.g., white blood cells, red blood cells, platelets)
Baseline and Week 12
ADHD Diagnostic Parent and Teacher Rating
大体时间：Baseline and Week 12

Change in ADHD symptom severity measured using the Vanderbilt ADHD Diagnostic Parent and Teacher Rating Scales. The symptom assessment includes 18 ADHD items corresponding to DSM criteria for inattentive and hyperactive-impulsive symptoms. Total symptom scores range from 0 to 54, with higher scores indicating greater ADHD symptom severity.

Scale Information:

Minimum score: 0 Maximum score: 54 Higher scores indicate worse ADHD symptoms.
Baseline and Week 12

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。

赞助

Khyber Medical University Peshawar

合作者

Khyber Teaching Hospital

调查人员

  • 首席研究员：Dr Dur E Shawar, PhD*、Khyber Medical University Peshawar, Pakistan
  • 首席研究员：Prof Dr Inayat Shah, PhD、Khyber Medical University Peshawar, Pakistan
  • 首席研究员：Prof Dr Omer Malik, PhD、Khyber Medical University Peshawar, Pakistan
  • 首席研究员：Dr Madiha Khattak, PhD、Khyber Medical College

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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 (实际的)

2026年3月1日

初级完成 (估计的)

2026年11月30日

研究完成 (估计的)

2026年12月25日

研究注册日期

首次提交

2026年6月16日

首先提交符合 QC 标准的

2026年6月22日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年6月24日

上次提交的符合 QC 标准的更新

2026年6月22日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • KMU/DIR/CTU/2026/02

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

IPD that underlie the results reported in publications, including demographic data, baseline characteristics, ADHD symptom scores, laboratory measurements, and intervention allocation data, will be shared after de-identification. Data will be provided in a manner that protects participant confidentiality and privacy. Supporting study documents including the study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code will also be made available. IPD that underlie the results reported in publications, including demographic data, baseline characteristics, ADHD symptom scores, laboratory measures, and intervention allocation data, will be shared after de-identification. Data will be provided in a manner that protects participant confidentiality and privacy. Supporting study documents including the study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code will also be made available.

IPD 共享时间框架

Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years thereafter.

IPD 共享访问标准

De-identified participant data and supporting documents will be made available to qualified researchers who provide a methodologically sound research proposal. Requests should be directed to the Principal Investigator. Access will be granted following review and approval of the proposal and execution of a data-sharing agreement that ensures participant confidentiality and compliance with applicable ethical and regulatory requirements.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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