NCT02708589Unknown2 期
The Effects of Probiotic Supplementation on Anthropocentric, Nutrients Status, Inflammation, GI Hormones, Quality of Life, and Microflora in Patients Undergoing Gastric Bypass Surgery
National Nutrition and Food Technology Institute2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- weigh of the participants will be measured in Kg.
研究概览
简要总结
In this study, patients undergoing the bariatric surgery will be assigned to take either probiotic capsules or placebos from 1 month before surgery to 3 months after the surgery. Their anthropometric and biochemical measurements will be assessed every 3-6 months, and will be compared in two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI> 40 or >35 plus other morbidities
- •Undergoing the gastric bypass surgery
- •Willing to participate in the study
排除标准
- •History of any chronic GI or kidney disorders, malignancies, or immune deficiencies
- •Taking any immunomodulatory or immunosuppressor medications
- •Taking Antibiotics from 4 weeks before and during the intervention
- •Being on special diet such as vegetarian diet
- •Doing as a professional Athlete
- •Pregnancy and Lactation
结局指标
主要结局
weigh of the participants will be measured in Kg.
时间窗: 3 months after surgery
次要结局
- serum level of vitamin D(ng/ml)(3 months after surgery)
- serum level of vitamin D (ng/ml)(12 months after surgery)
- serum level of vitamin B12 (mg/dl)(12 months after surgery)
研究者
Dr Azita Hekmatdoost
Associate Prof
National Nutrition and Food Technology Institute
研究点 (2)
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