None listed
Conditions
Interventions
Dietary Supplement : On Visit 1 (day 0), subject who voluntarily signs on the written informed consent is reviewed according to inclusion-exclusion criteria. Selected subject is randomly allocated to
Sponsors
Ewha Womans University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Subject who voluntarily agrees to participate and sign in informed consent form 2) 20 years= Age = 50 years 3) Men 4) Healthy bowel habit 5) Availability of internet connection 6) Smart phone user
Exclusion criteria
Exclusion criteria: 1) Previous cholera vaccination. 2) Other vaccination in the past 1 month. 3) Acute gastroenteritis in the past 2 months. 4) Use of antibiotics in the past 2 months. 5) Hypersensitivity to the vaccine, to formaldehyde, to any of the excipients (sodium salts) or to probiotics. 6) Disease of GI tract (constipation, diarrhea, IBD, etc), liver, gall bladder, kidneys, thyroid gland. 7) Immune-compromised. 8) Use of immunosuppressive drugs. 9) Drug abuse, and not willing/able to stop this during the study. 10) Continuous consumption of probiotics within 2 weeks prior to the study. 11) Excessive alcohol usage (140 g/week, about 3.5 bottles/week or 4 glasses/day as soju). 12) Participating in another clinical trial within 12 weeks prior to or during the study. 13) Visiting a country affected by cholera in the past 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal calprotectin level ;Cholera toxin-specific antibody level in plasma | — |
Secondary
| Measure | Time frame |
|---|---|
| Local and systemic inflammatory responses;Fecal microbiota;Bristol stool scale | — |
Countries
Korea, Republic of
Contacts
Public ContactMinyoung Park
Ewha Womans University
Outcome results
None listed