Healthy subjects
Conditions
Interventions
Group 1: 1000 µg vitamin B12 (cyanocobalamin as cobalamin concentrate), oral, 1x1 tablet, Intervention: 4 weeks
Sponsors
MEDICE Arzneimittel Pütter GmbH & Co KG
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: - 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Vitamin B12 status in serum (day 1, day 29) | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed