To investigate the effect of Bifidobacterium lactis CECT 8145 BPL1® on the seroconversion rate after influenza vaccination in healthy adults, compared to placebo treatment.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
immune modulation in healthy subjects
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of subjects with either a pre-vaccination HAI titer < 1:10 and a
post-vaccination HAI titer >= 1:40 or a pre-vaccination HAI titer >= 1:10 and a
minimum four-fold rise in post-vaccination HAI antibody titer.
Secondary outcome
• Geometric Mean Titre of influenza-specific antibodies
• Seroprotection
• Change in plasma cytokines (IL-10, IL-4, and TNF-alpha, IFN-gamma)
• Vaccine-specific plasma IgG concentrations
• Plasma total IgG concentrations
• Symptoms of respiratory tract infections (RTI)
• Gastrointestinal symptoms
• Adverse Events
Background summary
Vaccination response may be enhanced by oral supplementation with specific
probiotic strains. Preclinical study results for Bifidobacterium lactis CECT
8145 BPL1® indicate that this strain might be a good candidate for enhancement
of vaccine response. Influenza viruses are an important cause of respiratory
infections; influenza vaccination response in general is suboptimal. Intake of
BPL1® might contribute to enhanced influenza vaccination response and increased
resistance to infection. This is to be investigated in a human intervention
trial with this specific probiotic strain.
Study objective
To investigate the effect of Bifidobacterium lactis CECT 8145 BPL1® on the
seroconversion rate after influenza vaccination in healthy adults, compared to
placebo treatment.
Study design
The study is designed as a double-blind, randomized, placebo-controlled trial,
with two treatment arms. After a 2-week intervention period, all subjects will
receive an influenza vaccination.
Intervention
The active intervention group will receive Bifidobacterium lactis CECT 8145
BPL1® (BLP1®), as a food supplement. The placebo group will receive a
supplement in which BLP1® is replaced by maltodextrin, but indistinguishable in
appearance and taste. Interventions will be administered for a total of 6 weeks
(42 days).
Study burden and risks
The subjects will not benefit directly from participation in this study, apart
from receiving a subject fee for their time investment plus reimbursement of
traveling expenses. In case they are exposed to the influenza virus, after
their participation in the study, they may experience a benefit from the
influenza vaccination.
Potential risks could be related to a) study product, b) study procedures or c)
non-investigational product (influenza vaccination).
The probiotic study product BPL1® is widely marketed in Europe, North and South
America and Asia. There are no reported safety concerns for BPL1®.
The burden imposed by study procedures includes the daily intake of the study
product, the (4) visits to the research location, the blood sampling (at 3
visits), and the vaccination injection. The collection of blood samples may
produce discomfort or minor bleeding and the possibility of bruising at the
site of the needle puncture. There is also a slight risk of infection at the
site of the needle puncture. Side effects of flu vaccination that are reported
to occur more often are redness and pain on the injection site. In 10-30% of
the vaccinated population, flu-like symptoms such as headache, muscle soreness,
irritability or reduced appetite are reported, and in a few cases also mild
fever and fatigue, for 1-2 days. Overall, the risks associated with
participation in this study are considered small.
Calle Catedrático Agustín Escardino Benlloch, 9, Edificio 2
Parc Cientific de la Universitat de València, Paterna (Valencia C.P. 46980
ES
Calle Catedrático Agustín Escardino Benlloch, 9, Edificio 2
Parc Cientific de la Universitat de València, Paterna (Valencia C.P. 46980
ES
Listed location countries
Age
Inclusion criteria
1. Age >=16 and <=65
2. Self-reported regular Dutch eating habits as assessed by questionnaire (3
main meals per day)
3. Non-smokers (ex-smokers can participate if they stopped at least 6 months
before screening)
4. BMI >=18.5 and <=28
5. In good health as assessed during screening, and the medical investigator*s
professional judgment
6. Adherence to habitual diet, no changes during study period
7. Signed informed consent
Exclusion criteria
1. Influenza vaccination within 6 months before the start of the intervention
2. Any vaccination in the month before randomization (visit 1) or any scheduled
vaccination during the study period
3. Self-reported influenza infection within 6 months before the start of the
intervention
4. Acute infection (including gastroenteritis) within 2 months before start of
the intervention
5. Treatment with oral antibiotics within 2 months before the start of the
intervention
6. Serious progressive disease or non-stabilized chronic illness (e.g.,
diabetes mellitus, cardiac insufficiency, respiratory insufficiency, cancer,
chronic kidney or liver disease)
7. Gastrointestinal disorders (e.g., inflammatory bowel disease)
8. Immunodeficiency or autoimmune disorder
9. Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic
corticosteroids, antibodies)
10. Unexplained weight loss or weight gain of > 3 kg in the 3 months prior to
pre-study screening
11. Evidence of current excessive alcohol consumption (>4 consumptions/day or
>20 consumptions/week) or drug (ab)use
12. No change in use of immune boosting supplements during the study
13. Mental status that is incompatible with the proper conduct of the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82666.028.22 |