Intestinal Function of Patients With Uper Air and Digestive Neoplasia Submitted to Surgical Treatment: Symbiotic Use Impact
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Serum DAO Enzyme Concentration
研究概览
简要总结
The purpose of this study is to determine whether the symbiotic use in patients with head and neck cancer impact on intestinal function after surgical treatment.
详细描述
The study will be conducted offering the patients symbiotic product twice a day for seven days after the surgical treatment. Patients will be monitored for the number of stools, stools consistency, abdominal pain and gas overproduction.
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
- Triple (Participant, Care Provider, Investigator)
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
- •head and neck cancer with primary surgical treatment, enteral nutrition by enteral tube.
排除标准
- •three months antibiotic use earlier the surgery, recently radiotherapy or quimiotherapy, inflammatory bowel disease.
研究组 & 干预措施
Symbiotic
Patients will receive the symbiotic product LactoFos twice a day during seven days after surgical treatment. The intervention consists of giving twice a day a sachet of 6g of symbiotic diluted in 20mL of water via nasoenteric tube for seven days, totaling the administration of 14 sachets per intervention.
干预措施: Symbiotic (Dietary Supplement)
Maltodextrin
Patients will receive 6g of maltodextrin twice a day during seven days after surgical treatment.
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
Serum DAO Enzyme Concentration
时间窗: 7 days
The intestinal permeability using serum DAO enzyme concentration (ng/mL) was determined by sandwich enzyme-linked immunosorbent assay (ELISA) kit (SEA656Hu), according to Cloud-Clone Corporation® (Huston, TX) specifications.
次要结局
- Infection Rate(7 days)
研究者
Maria Isabel Toulson Davisson Correia
PhD
Federal University of Minas Gerais