NCT07459699招募中不适用
Randomised, Placebo-controlled Pilot Study to Assess the Effects of Probiotics on the Gut-brain Axis in Children With Attention Deficit Hyperactivity Disorder
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Probi AB
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score
研究概览
简要总结
The effect of probiotics on the gut-brain axis in children with attention deficit hyperactivity disorder will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 8 - 11 years
- •With mild ADHD symptoms
- •Patient and parents (legal representatives) able and willing to participate in the research by complying with the protocol procedures
排除标准
- •Metabolic disorder
- •Severe chronic disease
- •GI disorders found to be inconsistent with the conduct of the study by the investigator
- •Neurological disorder involving central function (e.g., intellectual disability, autism spectrum disorder, epilepsy, narcolepsy)
- •Currently treated with a medication with primary central nervous system activity or major psychiatric condition requiring hospitalization
- •With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredients
- •Having taken prebiotic or probiotic treatment in the month prior to inclusion, or having taken antibiotics for more than one week in the 3 months prior to inclusion,
- •Taking part in another clinical trial or being in the exclusion period of a previous clinical trial,
- •Parents (legal representatives) presenting a psychological or linguistic incapability to sign the ICF,
- •Parents (legal representatives) impossible to contact in case of emergency.
研究组 & 干预措施
Probiotics
Active Comparator
干预措施: Probiotics (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Conner's Continuous Performance test-3 (CPT-3) hit reaction time (HRT) block change score
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Probiotics for Autism Spectrum Disorders: a Randomized Controlled Trial (The PASD Study)Autism Spectrum DisorderNCT07345585Federico II University50
尚未招募
不适用
Effects of Lactic Acid Bacteria in Patients With Attention-Deficit/Hyperactivity Disorder：An Open Label Clinical ResearchNCT07419659I-Ching Chou80
已完成
2 期
Effect of Probiotic on Gut Microbiota in Young Children With Functional ConstipationNCT07360535Min-Tze LIONG84
尚未招募
不适用
Effect of probiotics on various parameters in diabetic and obese patientsCTRI/2024/09/073730UCMS and GTB Hospital60
尚未招募
4 期
Exploring the Benefits of Probiotics on Behavior and Gut Health in Children with AutismCTRI/2025/01/079295AIIMS Guwahati140