Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2016-08-31
2017-12-31
Brief Summary
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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 a previous study, this model was developed using oral cholera vaccination in human adult volunteers. In that study, raw milk was shown to support the immune response to vaccination. In this follow-up study, the effect of raw milk will be compared with pasteurized and ultra-heat treated (UHT) milk.
Objective: To investigate whether pasteurized milk and/or UHT milk are able to enhance the immune response as induced by oral cholera vaccination, in comparison to raw milk and to regular vaccination.
Study design: The study is designed as a single-blind randomized controlled trial of 6 weeks.
Study population: Healthy subjects of 18-50 years of age.
Interventions: 1) 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; 2) commercially available full-fat UHT milk; 3) commercially available full-fat pasteurized milk.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control group
Regular cholera vaccination
cholera vaccination
Oral cholera vaccination on day 0 and day 14
Raw milk
Cholera vaccination - raw milk
cholera vaccination
Oral cholera vaccination on day 0 and day 14
raw milk
raw milk
Pasteurized milk
Cholera vaccination - pasteurized milk
cholera vaccination
Oral cholera vaccination on day 0 and day 14
pasteurized milk
pasteurized milk
UHT milk
Cholera vaccination - UHT milk
cholera vaccination
Oral cholera vaccination on day 0 and day 14
UHT milk
UHT milk
Interventions
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cholera vaccination
Oral cholera vaccination on day 0 and day 14
raw milk
raw milk
pasteurized milk
pasteurized milk
UHT milk
UHT milk
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
* Availability of internet connection
* Male or female
* Willing to stop blood donation at the blood bank during the study period
Exclusion Criteria
* Previous Cholera, Salmonella, or E. coli vaccination
* Tonsillectomy
* Acute gastroenteritis in the past 2 months
* Use of antibiotics in the past 2 months
* Hypersensitivity to the vaccine, to formaldehyde or to any of the excipients (sodium salts)
* Pregnancy or lactating
* Not willing to drink raw milk
* Allergic to milk or lactose-intolerant
* Disease of GI tract, liver, gall bladder, kidneys, thyroid gland
* Immune-compromised
* Use of immunosuppressive drugs
* Drug abuse, and not willing/able to stop this during the study
* Excessive alcohol usage (men: \>4 consumptions/day or \>20 consumptions/week; women: \>3 consumptions/day or \>15 consumptions/week)
18 Years
50 Years
ALL
Yes
Sponsors
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FrieslandCampina
INDUSTRY
NIZO Food Research
OTHER
Responsible Party
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Principal Investigators
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Els van Hoffen, PhD
Role: PRINCIPAL_INVESTIGATOR
NIZO Food Research
Locations
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NIZO food research
Ede, , Netherlands
Countries
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Other Identifiers
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NL56906.081.16
Identifier Type: -
Identifier Source: org_study_id
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