Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Study Evaluating the Impact of Serum-derived Bovine Immunoglobulin Protein Isolate, a Medical Food, on Nutritional Status in HIV+ Subjects With HIV-associated Enteropathy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 14
- 主要终点
- Frequency of Daily Unformed Bowel Movements
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g twice a day (BID) and SBI 5.0 g versus placebo on supporting nutrient absorption in HIV+ subjects with HIV-associated enteropathy.
详细描述
This study is evaluating the effectiveness of the oral nutritional therapy serum-derived bovine immunoglobulin protein isolate (SBI) 2.5g BID and SBI 5.0g compared to placebo for 6 months on gastrointestinal symptoms, nutritional status and quality of life in HIV+ subjects with HIV-associated enteropathy. In addition, the effects of SBI on pro-inflammatory intestinal microbial populations, bacterial translocation, intestinal barrier function, and systemic immune activation will be investigated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of HIV-1 infection
- •Plasma HIV viral load ≤40 copies/mL
- •Maintained virologic suppression for 1 year
- •Stable Antiretroviral Therapy (ART) regimen
- •History of HIV-associated diarrhea defined as abnormal passage of 3 or more unformed stools per day or a liquid stool volume greater than 200 g per day for at least 4 weeks duration
排除标准
- •Positive stool test for pathogenic bacteria, C. difficile or ova and parasites
- •Conditions that require chronic therapy that is known to alter gut microbiota
- •Antibiotics within 2 weeks of screening (exception: prophylaxis antibiotics)
结局指标
主要结局
Frequency of Daily Unformed Bowel Movements
时间窗: Baseline and 4 weeks
Change in number of abnormal or unformed stools by week 4
次要结局
未报告次要终点