Effects of Lactobacillus Coryniformis CECT5711 on Immune Response to Influenza Vaccination in Adults Over 65.
Primary Purpose
Influenza Vaccination, Immune Response, Probiotics
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lactobacillus coryniformis K8 CECT5711
Control placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza Vaccination focused on measuring Lactobacillus coryniformis, Flu, Vaccine
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Probiotic
Arm Description
Capsules containing 300 mg of maltodextrin.
Capsules containing 3x10(9) colon-forming units of the strain L. coryniformis K8 CECT5711 in a matrix of maltodextrin.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of influenza-like illness
Number of cases of influenza-like illness during the follow-up period (5 months)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03167593
Brief Title
Effects of Lactobacillus Coryniformis CECT5711 on Immune Response to Influenza Vaccination in Adults Over 65.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (undefined)
Primary Completion Date
January 7, 2016 (Actual)
Study Completion Date
April 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosearch S.A.
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
The objective of the present study is to evaluate the capability of 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-blinded, placebo controlled, multicenter trial was performed. The study was started on October 2015 and ended on April 2016. The recruitment of volunteers was carried out in five nursing home of Granada (Spain) at the beginning of the vaccination program.
Volunteers were randomly assigned to one of two groups. Those in the placebo group daily consumed a capsule containing 300 mg of maltodextrin. Those in the probiotic group daily consumed a capsule containing 3x10(9) colon-forming units of the strain Lc K8 in a matrix of maltodextrin.
From two weeks previous to the beginning of the intervention the consumption of any probiotic supplement was restricted until the end of the study. During two weeks before flu vaccination volunteers daily received a capsule of probiotic or placebo. Day 15 of the study all volunteers received intramuscular vaccination against flu (inactivated trivalent influenza: A/California/7/22009[H1N1]pdm09, A/HongKong/4801/2014[H3N2], B/Brisbane/60/2002) for the vaccine campaign of 2015/2016 (Sanofi Pasteur Europe, Lyon, France). All volunteers were vaccinated during the same week (second week of November 2015). After vaccination volunteer were followed-up until 31 of April 2016.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Vaccination, Immune Response, Probiotics
Keywords
Lactobacillus coryniformis, Flu, Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Capsules containing 300 mg of maltodextrin.
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Capsules containing 3x10(9) colon-forming units of the strain L. coryniformis K8 CECT5711 in a matrix of maltodextrin.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus coryniformis K8 CECT5711
Other Intervention Name(s)
Probiotic group
Intervention Description
Lactobacillus coryniformis CECT5711
Intervention Type
Other
Intervention Name(s)
Control placebo
Intervention Description
Maltodextrin
Primary Outcome Measure Information:
Title
Percentage of seroconversion
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Incidence of influenza-like illness
Description
Number of cases of influenza-like illness during the follow-up period (5 months)
Time Frame
5 months
Other Pre-specified Outcome Measures:
Title
Cytokines
Description
Interleukin-10, interleukin-4, tumor necrosis factor -alpha
Time Frame
3 months
Title
Immunoglobulins
Description
Immunoglobulin A (IgA) and Immunoglobulin G (IgG)
Time Frame
3 months
Title
Gastrointestinal manifestations
Description
Nausea, vomits and lack of appetite during follow-up period
Time Frame
5 months
Title
Medication
Description
Consumption of analgesics and antibiotics during follow-up period
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Gracián, MD
Organizational Affiliation
Hospital de San Rafael, Granada (Spain)
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Lactobacillus Coryniformis CECT5711 on Immune Response to Influenza Vaccination in Adults Over 65.
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