A study to evaluate the immune health benefits of two selected probiotic strains

Randomised, double-blind, placebo-controlled trial to evaluate the impact of a minidrink or capsule containing selected probiotic strains on the immune response following an influenza vaccination in healthy adults

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64739181

Enrollment

220

Registered

2010-12-23

Start date

2009-02-20

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General immune defence Signs and Symptoms Immune defence

Interventions

Four different treatment arms are included in the study: 1. A capsule containing Bifidobacterium animalis ssp. lactis (BB-12®) in a dosage of minimum 1 billion CFU (colony forming units)/day 2. A plac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy male and female subjects 2. Aged 20 - 60 years old

Exclusion criteria

Exclusion criteria: 1. Presence of acute or terminal disease 2. Gastrointestinal disorders or surgery 3. Intolerance for milk protein or lactose 4. Daily consumption of probiotic products 5. Antibiotic treatment 6. Any vaccination 15 days prior to baseline 7. Prior influenza vaccination for the 2008/2009 season 8. Already having suffered from influenza during the 2008/2009 season

Design outcomes

Primary

Measure	Time frame
Antigen-specific response to the influenza vaccination in plasma and saliva 4 weeks after the vaccination.	—

Secondary

Measure	Time frame
General adaptive and innate immune responses to the influenza vaccination 4 weeks after the vaccination.	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026