WPMDE1 - Whey Protein Milk-Derived Exosomes Among Healthy Subjects- a Phase 1, Single-center, Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Tolerability of adverse symptoms over the study period.
研究概览
简要总结
This phase 1, single-center, open-label study aims to evaluate the tolerability and usability of WPMDE1, a whey protein milk-derived exosome (EV) nutritional supplement, in healthy adults. The study will assess dose tolerability and determine the appropriate dosage for future studies targeting patients with Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD).
详细描述
WPMDE1 is a nutritional supplement derived from cow's milk using a novel production process designed to preserve extracellular vesicles (EVs) and their biological functions. This single-arm, unblinded trial will explore the effects of ascending doses of WPMDE1 on tolerability and usability in up to 30 healthy adults aged 18-60. Participants will be divided into five groups to test incremental doses over 7-30 days.
The study includes blood sampling, vital sign measurements, and daily symptom tracking via validated gastrointestinal symptom questionnaires. The outcomes will inform the design of future clinical trials targeting IBS and IBD patients. The trial will be conducted at Hadassah University Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants who have not undergone any major surgeries or hospitalization 6 months prior to entering the study
- •All genders
- •Participants aged 18-60
- •Participants with no underlying known health or mental conditions
- •Participants who are not participating in another clinical study simultaneously or taking any other nutritional supplements or chronic drugs.
- •Participants must pre-sign the informed consent form.
排除标准
- •Participants who violate one or more of the inclusion criteria
- •participants with chronic diseases, particularly those that are related to the GI tract
- •Participants with cow milk allergy/ intolerance or history of such.
- •Participants suffering from constipation or diarrhea
- •Participants who use drugs or drink alcohol on a regular basis (more than one glass per week)
- •Pregnant or breastfeeding women
- •Participants with a BMI over 30
结局指标
主要结局
Tolerability of adverse symptoms over the study period.
时间窗: up to 30 days
Tolerability: Identification of dose ranges that do not cause discomfort or adverse symptoms over the study period.
次要结局
未报告次要终点