Effect of Raw Milk on the Immune Response Upon Cholera Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in cholera toxin-specific IgA and IgG antibody level in nasal wash as a marker of the vaccination response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Control group
Regular cholera vaccination
干预措施: Cholera vaccination (Biological)
Milk bolus
Cholera vaccination - raw milk - bolus
干预措施: Cholera vaccination (Biological)
Milk bolus
Cholera vaccination - raw milk - bolus
干预措施: Raw milk (Other)
Milk controlled
Cholera vaccination - raw milk - controlled intake
干预措施: Cholera vaccination (Biological)
Milk controlled
Cholera vaccination - raw milk - controlled intake
干预措施: Raw milk (Other)
结局指标
主要结局
Change in cholera toxin-specific IgA and IgG antibody level in nasal wash as a marker of the vaccination response
时间窗: baseline and day 18
次要结局
- Cholera toxin-specific T cell proliferation as marker of modulation of the vaccination response(baseline and day 28)
- 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)
- 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)