NCT03872245Unknown3 期
Association of Probiotics Intake With Percutaneous Electrical Neurostimulation of Dermatome T6 (PENS T6): Effect on Weight Loss in Obese Patients
Hospital General Universitario Elche0 个研究点目标入组 20 人开始时间: 2019年3月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 20
- 主要终点
- Weight loss
研究概览
简要总结
Patients will be randomized into 2 groups:
- Group 1:Patients undergoing PENS T6, who also received Probiotics, during 10 weeks.
- Group 2: Patients undergoing PENS T6 during 10 weeks. They will not received Probiotics
Weight loss after 10 weeks of treatmente will be assessed.
详细描述
Patients will be randomized into 2 groups:
- Group 1:Patients undergoing percutaneous electrical stimulation of dermatome T6 (PENS T6), who also received Probiotics (Adomelle 1 caps/12h), during 10 weeks.
- Group 2: Patients undergoing PENS T6 during 10 weeks. They will not received Probiotics
Weight loss after 10 weeks of treatmente will be assessed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 30 Kg/m2
排除标准
- •Patients with pacemakers or implanted electrical devices.
- •Pregnant women
- •History of allergy to Probiotics
研究组 & 干预措施
PENS T6 + Probiotics
Experimental
The patients will receive Probiotics (Adomelle 1caps/12h) associated to PENS T6 during 10 weeks.
干预措施: Probiotics (Biological)
PENS T6 + Probiotics
Experimental
The patients will receive Probiotics (Adomelle 1caps/12h) associated to PENS T6 during 10 weeks.
干预措施: PENS T6 (Procedure)
PENS T6
Active Comparator
The patients will undergo PENS T6 during 10 weeks.
干预措施: PENS T6 (Procedure)
结局指标
主要结局
Weight loss
时间窗: 10 weeks
Weight loss after treatment will be assessed
次要结局
未报告次要终点
研究者
Jaime Ruiz-Tovar, MD, PhD
Department of Surgery
Hospital General Universitario Elche
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