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| Name | Class |
|---|---|
| FrieslandCampina | INDUSTRY |
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Rationale: Infections are an important worldwide cause of death, both in elderly and young children. Therefore, support of immunity could help to reduce the incidence of infections. To screen the potential of specific foods or food ingredients to support immunity, oral vaccination can serve as a model. In this study, oral cholera vaccination will be applied in human adult volunteers, and used as a model to study the support of the immune response by raw milk.
Objective: To investigate whether raw milk is able to enhance the immune response as induced by oral cholera vaccination.
Study design: The study is designed as a single-blind randomized controlled trial of 4 weeks.
Study population: Healthy subjects of 18-50 years of age.
Intervention: Raw milk, obtained from farms that comply to the high quality requirements for production of raw milk, and that has been screened according to the safety criteria for raw milk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Regular cholera vaccination |
|
| Milk bolus | Experimental | Cholera vaccination - raw milk - bolus |
|
| Milk controlled | Experimental | Cholera vaccination - raw milk - controlled intake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholera vaccination | Biological | Oral cholera vaccination on day 0 and day 14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cholera toxin-specific IgA and IgG antibody level in nasal wash as a marker of the vaccination response | baseline and day 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the cholera toxin-specific IgA and IgG antibody level in serum as a marker of the vaccination response | baseline and day 18 | |
| Change in the cholera toxin-specific IgA antibody level in feces as a marker of the vaccination response | baseline and day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Els van Hoffen, PhD | NIZO Food Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIZO food research | Ede | 6718 ZB | Netherlands |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C586175 | Dukoral |
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| Raw milk | Other |
|
| Change in the cholera toxin-specific IgA and IgG antibody level in saliva as a marker of the vaccination response | baseline and day 18 |
| Change in the expression of tissue homing markers on IgA and IgG antibody-secreting B cells in peripheral blood as markers of the route of modulation of the vaccination response | baseline and day 18 |
| Cholera toxin-specific T cell proliferation as marker of modulation of the vaccination response | baseline and day 28 |