The effect of Lactobacilli on the immune system of healthy adults

Completed

• Conditions: General immune defence; Haematological Disorders

• Registration Number: ISRCTN08280229
• Lead Sponsor: Chr. Hansen A/S (Denmark)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-28
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1058

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified