Infection Clinical Trial
Official title:
MOSAIC-2: Effect of Raw Milk on the Immune Response Upon Cholera Vaccination
Rationale: Oral vaccination is known to induce a systemic immune response as well as an
immune response in mucosal tissues, and can therefore serve as a model to study systemic and
mucosal immunity. In this study, the oral cholera vaccine Dukoral® was chosen as model
vaccine. The kinetics of the immune response and the interaction with a raw milk matrix have
been evaluated in a previous, pilot study (NL49042.081.14). Based on the outcomes of this
pilot, in this study oral cholera vaccination will be applied to study the support of
immunity by raw milk, compared to heat-treated milk. The study design has been optimised
based on previous results: study duration is extended and sample size is based on relevant
change and known variation in the primary outcome parameters.
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 a previous study, this model was developed using oral cholera
vaccination in human adult volunteers. In that study, raw milk was shown to support the
immune response to vaccination. In this follow-up study, the effect of raw milk will be
compared with pasteurized and ultra-heat treated (UHT) milk.
Objective: To investigate whether pasteurized milk and/or UHT milk are able to enhance the
immune response as induced by oral cholera vaccination, in comparison to raw milk and to
regular vaccination.
Study design: The study is designed as a single-blind randomized controlled trial of 6 weeks.
Study population: Healthy subjects of 18-50 years of age.
Interventions: 1) 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; 2) commercially available full-fat UHT milk; 3) commercially available full-fat
pasteurized milk.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04529421 -
Assocation Between In-person Instruction and COVID-19 Risk
|
||
| Recruiting |
NCT04081792 -
Optimal Antibiotics for Operated Diabetic Foot Infections
|
N/A | |
| Completed |
NCT04332861 -
Evaluation of Infection in Obstructing Urolithiasis
|
||
| Recruiting |
NCT04674657 -
Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
|
||
| Enrolling by invitation |
NCT05052203 -
Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
|
||
| Recruiting |
NCT00342589 -
New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
|
||
| Completed |
NCT03295825 -
Heparin Binding Protein in Early Sepsis Diagnosis
|
N/A | |
| Completed |
NCT03296423 -
Bacillus Calmette-guérin Vaccination to Prevent Infections of the Elderly
|
Phase 4 | |
| Withdrawn |
NCT04217252 -
Clinical Application of High-throughput Sequencing Technology for the Diagnosis of Patients With Severe Infection
|
N/A | |
| Recruiting |
NCT02899143 -
Short-course Antimicrobial Therapy in Sepsis
|
Phase 2 | |
| Recruiting |
NCT02905552 -
Myelodysplasic Syndromes and Risk Factors for Infection
|
N/A | |
| Withdrawn |
NCT02904434 -
Gastrointestinal Implications of Voriconazole Exposure
|
||
| Active, not recruiting |
NCT02768454 -
Antimicrobials Stewardship by Pharmacist
|
N/A | |
| Completed |
NCT02219776 -
Decreasing Infection In Arthroscopic Shoulder Surgery
|
N/A | |
| Completed |
NCT02210169 -
RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates
|
N/A | |
| Recruiting |
NCT02098226 -
Evaluation of MALDI Biotyper CA System for Detection of Gram- and Gram+ Bacteria and Yeasts
|
N/A | |
| Completed |
NCT01846832 -
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
|
Phase 3 | |
| Completed |
NCT01434797 -
Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection
|
||
| Terminated |
NCT01441206 -
Safety and Pharmacokinetics of Single and Multiple Dose Rifampin in Infants
|
Phase 1 | |
| Completed |
NCT01159834 -
Human Papillomavirus (HPV) Vaccination in Barretos (Pio XII Foundation - Barretos Cancer Hospital)
|
N/A |