General immune defence Haematological Disorders
Conditions
Interventions
Two different treatment arms are included in the study:
1. A milk drink containing the probiotic strain Lactobacillus paracasei ssp. paracasei, L. casei 431® in a dosage of minimum 1 billion Colony fo
Sponsors
Chr. Hansen A/S (Denmark)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women in a general good state of health, age 18-60 years both inclusive 2. Body mass index (BMI) 19-30 kg/m2 3. Provided voluntary written informed consent 4. No antibiotics during the run-in period 5. Subject has been able to abstain from fermented dairy products (such as yoghurts) as well as food and food supplements containing probiotics during the run-in period
Exclusion criteria
Exclusion criteria: 1. Chronic immunological disease 2. No cancers within the past five years 3. Influenza vaccination current season or has already suffered from influenza during the current season 4. Acute disease requiring treatment 5. Use of immunosuppressant medication 6. Lactose intolerance or milk protein allergy 7. Hypersensitivity to any of the components of the vaccine 8. Recent complicated gastrointestinal (GI) surgery that may have an impact on GI tract function 9. Oral antibiotics within one month prior to the screening visit 10. Elite athletes 11. Participation in another clinical trial within the past month 12. For pre-menopausal women: pregnant or lactating, or wish to be pregnant during the study and not willing to use reliable contraceptive methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Haemagglutinin inhibition titers in serum 3 weeks after the vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Antigen-specific antibody response to the influenza vaccination 3 weeks after the vaccination | — |
Countries
Denmark, Germany
Outcome results
None listed