Effect of Raw Milk on the Immune Response Upon Cholera Vaccination

Infection Clinical Trial

— MOSAIC  

Official title:

Effect of Raw Milk on the Immune Response Upon Cholera Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238548
• Other study ID #: NL49042.081.14
• Status: Completed
• Phase: N/A
• First received: September 9, 2014
• Last updated: March 28, 2017
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: NIZO Food Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2016
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cholera
• Infection

Intervention

Biological:
• Cholera vaccination
Oral cholera vaccination on day 0 and day 14

Other:
• Raw milk

Locations

Country	Name	City	State
Netherlands	NIZO food research	Ede

Sponsors (2)

Lead Sponsor	Collaborator
NIZO Food Research	FrieslandCampina

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the cholera toxin-specific IgA and IgG antibody level in serum as a marker of the vaccination response		baseline and day 18
Secondary	Change in the cholera toxin-specific IgA antibody level in feces as a marker of the vaccination response		baseline and day 28
Secondary	Change in the cholera toxin-specific IgA and IgG antibody level in saliva as a marker of the vaccination response		baseline and day 18
Secondary	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
Secondary	Cholera toxin-specific T cell proliferation as marker of modulation of the vaccination response		baseline and day 28