NCT01798329Unknown3 期
Minimal Hepatic Encephalopathy in Pre-hepatic Portal Hypertension Due to Portal Vein Thrombosis in Childhood and Young Adult: epidemiOlogical Study and Pilot Interventional Study.
A.O. Ospedale Papa Giovanni XXIII3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- neuropsychological and electrophysiological aspects
研究概览
简要总结
The aim of the study is:
- Epidemiological/observational: investigating the presence of neuropsychological and electrophysiological alterations, suggesting a condition of minimal hepatic encephalopathy(and its behavioral correlates), in childhood and young adulthood affected by pre-hepatic portal hypertension due to portal vein thrombosis, even for implementing specific diagnostic protocols.
- Interventional: collecting preliminary data on the effects of a probiotic, in order to implement a controlled clinical study.
详细描述
Epidemiological/observational study investigating the presence of neuropsychological and electrophysiological alterations, suggesting a condition of minimal hepatic encephalopathy(and its behavioral correlates), in childhood and young adulthood affected by pre-hepatic portal hypertension due to portal vein thrombosis, even for implementing specific diagnostic protocols
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •extra-hepatic portal vein thrombosis
- •4-20 years
- •knowledge of italian language
- •absence of perceptive or communicative deficit
- •absence of psychiatric disease or mental retardation
排除标准
- •medical contraindications for required evaluations
- •infective pathologies
- •parenchymal hepatic pathologies
结局指标
主要结局
neuropsychological and electrophysiological aspects
时间窗: after 15 weeks of probiotic or placebo treatment
Improvement in the spectrum of the digitalised electroencephalogram, improvement in the performance of the psychometric tests
次要结局
- biochemical blood test(after 15 weeks of probiotic or placebo treatment)
- urine and faeces analysis(after 15 weeks of probiotic or placebo treatment)
- abdomen scan with color doppler technique(after 15 weeks of probiotic or placebo treatment)
- neurological evaluation(after 15 weeks of probiotic or placebo treatment)
- dietary anamnesis (last three days)(after 15 weeks of probiotic or placebo treatment)
- bowel frequency and characteristics(after 15 weeks of probiotic or placebo treatment)
研究者
Dr. Lorenzo D'Antiga
MD, Director of Pediatric Unit
A.O. Ospedale Papa Giovanni XXIII
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Minimal HePatic Encephalopathy Among CiRrhotics. A Cross SEctional, Clinico-EpidEmiological, Multi-Centre, Study in Patients of PakisTanHepatic EncephalopathyNCT02613858Abbott550
已完成
不适用
Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal HypertensionPortal HypertensionCirrhosisNCT04807803IHU Strasbourg82
撤回
不适用
HepQuant to Predict Hepatic Encephalopathy After TIPSCirrhosis, LiverHepatic EncephalopathyNCT04664621Northwestern University
Unknown
不适用
Detection of Epileptiform Activity in Severe PreeclampsiaPreeclampsiaNCT03494517Pascal Vuilleumier35
已完成
不适用
Etiology and Early Diagnosis of Neurodevelopmental DisordersNeurodevelopmental DisordersNCT02003170University of Arkansas576