NCT02238548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

September 9, 2014

Last Update Submit

March 28, 2017

Conditions

Infection

Keywords

immunityvaccinationmilk

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

  • 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

Study Arms (3)

Control group

PLACEBO COMPARATOR

Regular cholera vaccination

Biological: Cholera vaccination

Milk bolus

EXPERIMENTAL

Cholera vaccination - raw milk - bolus

Biological: Cholera vaccinationOther: Raw milk

Milk controlled

EXPERIMENTAL

Cholera vaccination - raw milk - controlled intake

Biological: Cholera vaccinationOther: Raw milk

Interventions

Cholera vaccinationBIOLOGICAL

Oral cholera vaccination on day 0 and day 14

Also known as: Dukoral
Control groupMilk bolusMilk controlled
Raw milkOTHER
Milk bolusMilk controlled

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIZO food research

Ede, 6718 ZB, Netherlands

Location

MeSH Terms

Conditions

Infections

Interventions

Dukoral

Study Officials

  • Els van Hoffen, PhD

    NIZO Food Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 12, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2016

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

NL(1)