Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Urinary Lactulose: Mannitol Intestinal Permeability Test
研究概览
简要总结
Several host factors underlie the pathogenesis of the reciprocal cycle of childhood diarrhea and undernutrition in developing countries. These include intestinal inflammation, mucosal damage, and alterations in intestinal barrier function that lead to malabsorption, growth failure, and heightened susceptibility to recurrent and prolonged episodes of diarrhea. Recent studies from Northeast Brazil demonstrate the benefits of a novel alanyl-glutamine-based oral rehydration and nutrition therapy (Ala-Gln ORNT) in speeding the recovery of damaged intestinal barrier function in cell culture, animal models, patients with AIDS, and underweight children.
Oral supplementation with Alanyl-Glutamine (Ala-Gln; 24g a day for 10 days) improves short-term gut integrity and weight velocity 4 months after therapy in a group of undernourished children from Northeast Brazil. Intervention and Mechanisms of Alanyl-Glutamine for Inflammation, Nutrition, and Enteropathy (IMAGINE) is a study designed to answer the following questions: 1) What is the lowest dose of Ala-Gln that improves intestinal barrier function, intestinal inflammation, and nutritional status in children at risk of underweight, wasting, or stunting? 2) What are the mechanisms by which Ala-Gln exerts these benefits?
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who are undernourished or at risk of undernutrition, with anthropometric z-scores less than or equal to -1 for one of these parameters: height-for-age, weight-for-age, or weight-for-height.
- •Children ages 2 months to 5 years old.
排除标准
- •Children who are exclusively breastfed.
- •Have participated in another intervention study in the past two years.
- •Fever greater than 38.8 ° C.
- •Use of antibiotics.
- •Systemic disease or other serious medical condition (including, but not limited to meningitis, pneumonia, tuberculosis, and chickenpox).
- •Children who are unable to ingest, retain or absorb nutritional supplements.
- •Children whose families plan to move from the study area within the next 6 months.
结局指标
主要结局
Urinary Lactulose: Mannitol Intestinal Permeability Test
时间窗: Urine Collection on Day 1, 10-13, 30-37
Determine the dose-and time-effect of alanyl-glutamine on intestinal barrier function recovery using the intestinal permeability test, with measurement of the percentage of urinary excretion of lactulose, mannitol and ratio of lactulose:mannitol.
次要结局
- Fecal Lactoferrin Test(Fecal sample collected on Day 1, 10-13, 30-37)
- Fecal Cytokine Measurement(Fecal sample collected on Day 1, 10-13)
- Anthropometry(Measured and calculated Day 1, 10-13, 30-37, 90-104, 120-141)
- Fecal Calorimetry(Fecal sample collected on Day 1, 10-13, 30-37)
- Metabolomic Profile of Urine(Collected on Day 1, 10-13, 30-37)
- History of Diarrhea in the Previous Two Weeks(Day 1, 30-37, 90-104, 120-141)