NCT05603416进行中（未招募）不适用
Investigation of Benegut® on Immediate GI Discomfort Relief Caused by Acute Overfeeding in Healthy Subjects- a Randomized, Placebo-controlled Cross-over Study
Vital Solutions GmbH2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Overall gastrointestinal discomfort assessed with a visual analogue scale (VAS)
研究概览
简要总结
To determine the relief of GI discomfort after overfeeding with a high caloric meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
- •Age ≥ 25 and ≤ 70 years
- •BMI: 19-30 kg/m2
- •Overall GI discomfort after high caloric meal of at least 5 on the VAS scale
- •Male or female
- •Written consent to participate in the study
- •Subject is able and willing to follow the study protocol procedures
- •If applicable, stable intake of chronic medication of at least 3 months
排除标准
- •Criteria for inclusion:
- •Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
- •Age ≥ 25 and ≤ 70 years
- •BMI: 19-30 kg/m2
- •Overall GI discomfort after high caloric meal of at least 5 on the VAS scale
- •Male or female
- •Written consent to participate in the study
- •Subject is able and willing to follow the study protocol procedures
- •If applicable, stable intake of chronic medication of at least 3 months
- •Criteria for exclusion:
- •Relevant history, presence of any medical disorder (e.g. cancer, severe liver disease, severe renal disease, severe cardiovascular disease)
- •Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or use of PPI (proton pump inhibitors) or other digestive auxiliaries potentially interfering with this study at screening
- •Intake of antibiotics in the last 4 weeks
- •Women suffering from distinct PMS symptoms
- •Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
- •Change of dietary habits within the 4 weeks prior to screening (for instance start of a diet high in fibers)
- •Vegetarian or vegan nutrition style
- •Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
- •Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study.
- •Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study
- •Subject who according to the study staff's opinion is not suitable for participation in the study
结局指标
主要结局
Overall gastrointestinal discomfort assessed with a visual analogue scale (VAS)
时间窗: Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes)
In the current study, GI discomfort, following a high caloric meal, will be assessed with a visual analogue scale (VAS) before and after meal at defined timepoints.
次要结局
- Follow up assessment of gastrointestinal symptoms on a 6-point Likert scale(Day 1 immediately prior going to bed, day 2 immediately after wake up)
- Monitoring of related adverse events(up to 14 hours after intake)
- Assessment of gastrointestinal symptoms on a 6-point Likert scale(Chance over time after single dosage (pre, 0 minutes and after 5 minutes,15 minutes, 30 minutes, 45 minutes, 60 minutes, 90 minutes))
研究者
研究点 (2)
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