Glutamine Supplementation and Immunity in Adults With Cystic Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12.
研究概览
简要总结
Patients with cystic fibrosis develop frequent and potentially life-threatening lung infections. Recent studies suggest that the nutrient "glutamine" may help the body fight off infection. Glutamine is an amino acid; a type of nutrient the body requires to build muscle. It is one of the building blocks of protein. During an illness, blood levels of glutamine tend to be lower than normal. Also, many patients with cystic fibrosis have difficulty getting normal levels of nutrients from food. The aim of this study is to see if patients with cystic fibrosis have low levels of glutamine when they experience an infection, and whether a dietary glutamine supplement taken daily for three months can raise these levels. We also want to see if this supplement can improve other blood markers of immunity (the body's ability to defend itself from infection). We hope to enroll 40 people with cystic fibrosis who experience a lung infection, over a one year period, into this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult patients (≥ 18 years of age) with cystic fibrosis who give informed consent
- •Patients must have a clinically diagnosed pulmonary exacerbation at time of enrollment, characterized by clinical requirement for oral or intravenous antibiotics associated with pulmonary symptoms such as increased cough or decreased forced expiratory volumes (FEV1)
- •Participants must agree to provide phlebotomy samples and complete all study protocol at presentation and at return visits
排除标准
- •Any patients taking specific glutamine supplements within 30 days of enrollment
- •Pregnant or lactating women
- •Patients involved in any other research protocol involving intake of a study drug, in the last 60 days.
- •Patients who are chronically immunosuppressed due to drugs or immunosuppressive illness other than CF (e.g. HIV/AIDS, chronic autoimmune disease)
- •Patients receiving hemodialysis or with creatinine >2.5mg/dL
- •Patients with liver failure from any cause
- •Patients with a history of cancer within the past 12 months or currently receiving anti-neoplastic therapy.
- •Patients with a history of seizures
结局指标
主要结局
Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12.
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Thomas R. Ziegler, MD
Professor
Emory University