Effect of Raw Milk on the Immune Response Upon Cholera Vaccination

NCT ID: NCT02238548

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-12-31

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.

Conditions

Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control group

Regular cholera vaccination

Group Type: PLACEBO_COMPARATOR

Cholera vaccination

Intervention Type: BIOLOGICAL

Oral cholera vaccination on day 0 and day 14

Milk bolus

Cholera vaccination - raw milk - bolus

Group Type: EXPERIMENTAL

Cholera vaccination

Intervention Type: BIOLOGICAL

Oral cholera vaccination on day 0 and day 14

Raw milk

Intervention Type: OTHER

Milk controlled

Cholera vaccination - raw milk - controlled intake

Group Type: EXPERIMENTAL

Cholera vaccination

Intervention Type: BIOLOGICAL

Oral cholera vaccination on day 0 and day 14

Raw milk

Intervention Type: OTHER

Interventions

Cholera vaccination

Oral cholera vaccination on day 0 and day 14

Intervention Type: BIOLOGICAL

Raw milk

Intervention Type: OTHER

Other Intervention Names

Dukoral

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FrieslandCampina

INDUSTRY

Sponsor Role: collaborator

NIZO Food Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Els van Hoffen, PhD

Role: PRINCIPAL_INVESTIGATOR

NIZO Food Research

Locations

NIZO food research

Ede, , Netherlands

Countries

Netherlands

Other Identifiers

NL49042.081.14

Identifier Type: -

Identifier Source: org_study_id