DRKS00023744已完成未知
Clinical Study to Assess the Impact of a Bacterial- and Yeast-based Nutritional Supplement (AlcoDeTox) on Ethyl Alcohol Absorption in the Intestine Tract
Peradil AB0 个研究点目标入组 24 人开始时间: 2020年12月1日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
There was a significant reduction of blood alcohol levels by 70.3 % (p < 0.005) with AB001, when compared to placebo. There was a less pronounced but also significant reduction of alcohol in the breath test 30.7 % (p < 0.005), when compared to placebo. No difference in the cognitive function test between AB001 and placebo could be observed 60 min after alcohol ingestion (22.4±7.7 s vs. 22.7±5.6, n.s.). The supplement uptake was well tolerated. There were no adverse events or serious adverse events reported in this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Age > 18 years and = 75 years
- •2. Caucasian
- •3. Not suffering from any major disease
- •4. Willing to perform the two drinking experiments
- •5. No alcohol consumption within 7 days prior to study participation (negative EtG urine test
- •6. Negative Drug Screening test
- •7. Negative pregnancy test
排除标准
- •1. Acute or chronic disease
- •2. Present or History of alcohol addiction
- •3. Known allergy against probiotic nutritional supplements
- •4. Participation in a clinical trial within 3 months before trial entry.
- •5. Progressive fatal diseases
- •6. Participants taking medication (including non-prescription drugs)
- •7. Participants taking other dietary supplements
- •8. Past or current drug or alcohol abuse
- •9. Pregnancy or breast feeding
- •10. Lack of compliance or other similar reason, that, the investigator believes, precludes satisfactory participation in the study
研究者
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