NCT02750787已完成不适用
An Evaluation of the Use of a Peptide-based Formula in an Adult Population
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Study Product Consumption
研究概览
简要总结
The study is designed to observe the use of a peptide-based oral nutrition supplement in adults with chronic malabsorption or maldigestion who require supplemental nutrition as assessed by a clinician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Subject is ≥ 18 years of age.
- •Subject has chronic malabsorption or maldigestion.
- •Subject requires supplemental nutrition as assessed by a clinician.
- •Subject agrees to consume 2 servings of the study product a day for at least 16 consecutive days during Treatment period.
排除标准
- •Subject is currently taking or has taken antibiotics within 2 weeks prior to enrollment in the study.
- •Subject has current active malignant disease or was treated within the last 6 months for cancer.
- •Subject has a history of diabetes mellitus.
- •Subject is pregnant as demonstrated by a urine pregnancy test.
- •Subject has severe auto immune disease and is on immuno-modulating therapy.
- •Subject has a history of allergy to any of the ingredients in the study product.
- •Subject has active HIV.
- •Subject has a known aversion to flavor of product being tested.
- •Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption.
- •Subject has an obstruction of the gastrointestinal tract precluding ingestion or absorption of the study product.
- •Subject is taking part in another non-Sponsor approved clinical trial.
研究组 & 干预措施
Nutritional Study Product
Experimental
A ready-to-drink peptide-based liquid formula for patients with impaired gastro-intestinal function.
干预措施: Nutritional Study Product (Other)
结局指标
主要结局
Study Product Consumption
时间窗: Day 1 to Day 23
Subject Diary
次要结局
- Body Mass Index(Change from Screening to Day 23)
- Medication Use(Screening to Study Day 23)
- Adverse Events(Screening to Day 25)
研究者
研究点 (2)
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