Probiotics Clinical Trial
Official title:
Evaluation of the Effects of Consumption of the Probiotic Strain Lactobacillus Coryniformis CECT5711 on the Immune Response to Influenza Vaccine in Adults Over 65 Years of Age.
Verified date | May 2017 |
Source | Biosearch S.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of the present study is to evaluate the capability of the probiotic strain
Lactobacillus coryniformis K8 CECT5711 (Lc K8) to enhance the immune response to influenza
vaccine in elderly and the effect on respiratory symptoms related to respiratory infections.
A randomized, double-blind, placebo-controlled trial was conducted between November of 2015
and April of 2016. A total of 98 residents of nursing homes aged more than 65 years were
randomly assigned to receive Lc K8 or placebo for two weeks previous to influenza
vaccination.
Primary outcome was the percentage of seroconversion. Secondary outcome were the incidence
of influenza-like illness and respiratory symptoms associated to respiratory infections
during the follow-up period of 5 months. Serum cytokines and immunoglobulins levels were
also evaluated.
Status | Completed |
Enrollment | 98 |
Est. completion date | April 30, 2016 |
Est. primary completion date | January 7, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Residents in nursing home aged more than 65 years Exclusion Criteria: - Frequent gastrointestinal diseases, antibiotic treatment during the intervention, allergy to any groups of antibiotics, egg proteins or adjuvants and excipients of the flu vaccine |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Biosearch S.A. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cytokines | Interleukin-10, interleukin-4, tumor necrosis factor -alpha | 3 months | |
Other | Immunoglobulins | Immunoglobulin A (IgA) and Immunoglobulin G (IgG) | 3 months | |
Other | Gastrointestinal manifestations | Nausea, vomits and lack of appetite during follow-up period | 5 months | |
Other | Medication | Consumption of analgesics and antibiotics during follow-up period | 5 months | |
Primary | Percentage of seroconversion | According to the European Centre for Disease Prevention and Control (ECDC) for population older than 60 years old, seroconversion corresponds to the proportion of vaccinated individuals achieving a haemagglutination-inhibition (HAI) titre of >1:40 or a significant increase in HAI antibody titre, i.e. at least a four-fold titre increase. | 2 months | |
Secondary | Incidence of influenza-like illness | Number of cases of influenza-like illness during the follow-up period (5 months) | 5 months |
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