Effect of Raw Milk on the Immune Response Upon Cholera Vaccination

Not Applicable

Completed

• Conditions: Infection
• Interventions: Biological: Cholera vaccination; Other: Raw milk

• Registration Number: NCT02238548
• Lead Sponsor: NIZO Food Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-12
• Primary Completion: 2014-11
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milk bolus	Cholera vaccination	Cholera vaccination - raw milk - bolus
Milk controlled	Raw milk	Cholera vaccination - raw milk - controlled intake
Control group	Cholera vaccination	Regular cholera vaccination
Milk bolus	Raw milk	Cholera vaccination - raw milk - bolus
Milk controlled	Cholera vaccination	Cholera vaccination - raw milk - controlled intake

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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
Change in the cholera toxin-specific IgA and IgG antibody level in saliva as a marker of the vaccination response	baseline and day 18

Trial Locations

Locations (1)

NIZO food research; 🇳🇱 Ede, Netherlands