Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- change of LDL cholesterol after 6 months of treatment wiyh symbiotic
研究概览
简要总结
Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a combination of probiotic and prebiotics and amine in the treatment of children affected by familial hypercholesterolemia (FH).
详细描述
FH subjects, aged 6-12 years, consecutively observed a Tertiary Center for Pediatric Nutrition were randomly allocated to two groups of intervention for 6 months: active group, received a low saturated fats diet plus the symbiotic (2.5×109cfu, bid) for 6 months; control group, received low saturated fats diet alone. All children received written indications for low saturated fats diet. The plasmatic lipid profile was assessed by peripheral blood sampling at T0 and T1.
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
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged ≥ 6 and ≤ 12 years.
- •Diagnosis of hypercholesterolemia (LDL cholesterol> 140 mg / dl)
- •Each patient must have shown resistance to dietary therapy lasting at least 6-12 months.
排除标准
- •Age <6 or> 12 years.
- •Patients undergoing drug treatment for hypercholesterolemia.
- •Any medical condition that may interfere with participation in this study
- •Participation in clinical trials still in progress.
- •Taking pre / probiotics for more than 7 days in the 6 months prior to enrollment
结局指标
主要结局
change of LDL cholesterol after 6 months of treatment wiyh symbiotic
时间窗: The plasmatic lipid profile was assessed by peripheral blood sampling at enrollment and after 6 months.
次要结局
未报告次要终点
研究者
Roberto Berni Canani
MD,pHd
Federico II University