DRKS00033546已完成Unknown
Effect of oral vitamin B12 supplementation on human gut microbiome - BTS2001/23 - MEDICE Study Code 6630-4200-43
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry, haematology
- •-BMI =19 and =32 kg/m²
- •- Stool frequency 4 – 7x per week
- •- Non-smoker
- •-Written informed consent to participate in the study
- •-Able and willing to follow the study protocol procedures
排除标准
- •- Active or recent vitamin B12 intake (the subject must not receive vitamin B12 drugs or food supplements for at least 3 months).
- •- Anemia (female Hb <12.0 g/dL; male Hb <13.5 g/dL)
- •- Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
- •- Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, use of PPIs, bismuth salts and/or H2-antagonists
- •- Blood liver enzymes ALT, AST or GGT > 3xULN (Upper Limit of Normal)
- •- Significant changes in lifestyle or medication (within last 3 mo.) or planned during the study
- •-Intake of antibiotics in the last 2 months and laxatives in the last 2 weeks
- •-Subject had undergone resection of the stomach and/or intestine
- •- Performed colonoscopy within the last 4 weeks or planned during the study
- •-Subject with known intrinsic-factor or parietal cell antibodies
- •- Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study.
- •- Relevant allergy or known hypersensitivity against compounds of the study preparations
- •- Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
- •- Anticipating any planned changes in lifestyle or physical activity levels for the duration of the study
- •- If female: currently pregnant, planning to become pregnant during the study period, breastfeeding (a pregnancy test will be conducted).
- •- Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
- •- Subject not willing to avoid pre- and probiotics for the duration of the study.
研究者
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