NCT02238548

Effect of Raw Milk on the Immune Response Upon Cholera Vaccination

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: NIZO Food Research · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Cholera vaccination	Oral cholera vaccination on day 0 and day 14
OTHER	Raw milk

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-11-01
• Completion: 2016-12-01
• First posted: 2014-09-12
• Last updated: 2017-03-29

Locations

1 site across 1 country: Netherlands