Effect of Raw Milk on the Immune Response Upon Cholera Vaccination (MOSAIC)

March 28, 2017 updated by: NIZO Food Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Ede, Netherlands, 6718 ZB
        • NIZO food research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-50 yr
  • 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:

  • Currently participating in another clinical trial
  • 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 (pregnancy test will be performed on the vaccination days)
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Regular cholera vaccination
Biological: Cholera vaccination
Oral cholera vaccination on day 0 and day 14
Other Names:
  • Dukoral
Experimental: Milk bolus
Cholera vaccination - raw milk - bolus
Biological: Cholera vaccination
Oral cholera vaccination on day 0 and day 14
Other Names:
  • Dukoral
Other: Raw milk
Experimental: Milk controlled
Cholera vaccination - raw milk - controlled intake
Biological: Cholera vaccination
Oral cholera vaccination on day 0 and day 14
Other Names:
  • Dukoral
Other: Raw milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cholera toxin-specific IgA and IgG antibody level in nasal wash as a marker of the vaccination response
Time Frame: baseline and day 18
baseline and day 18

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the cholera toxin-specific IgA and IgG antibody level in serum as a marker of the vaccination response
Time Frame: baseline and day 18
baseline and day 18
Change in the cholera toxin-specific IgA antibody level in feces as a marker of the vaccination response
Time Frame: baseline and day 28
baseline and day 28
Change in the cholera toxin-specific IgA and IgG antibody level in saliva as a marker of the vaccination response
Time Frame: baseline and day 18
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
Time Frame: baseline and day 18
baseline and day 18
Cholera toxin-specific T cell proliferation as marker of modulation of the vaccination response
Time Frame: baseline and day 28
baseline and day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NIZO Food Research

Collaborators

FrieslandCampina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 11, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 28, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL49042.081.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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