Effect of oral vitamin B12 supplementation on human gut microbiome
- Conditions
- Healthy subjects
- Registration Number
- DRKS00033546
- Lead Sponsor
- MEDICE Arzneimittel Pütter GmbH & Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
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
- 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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of microbiome composition (16S-rRNA analysis) with alpha diversity, beta diversity and relative abundance of selected bacteria over a period of 28 days
- Secondary Outcome Measures
Name Time Method Vitamin B12 status in serum (day 1, day 29)