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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
Biosearch S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza Vaccination focused on measuring Lactobacillus coryniformis, Flu, Vaccine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 23, 2017
    Last Updated
    May 24, 2017
    Sponsor
    Biosearch S.A.
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    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

    Learn more about this trial

    Effects of Lactobacillus Coryniformis CECT5711 on Immune Response to Influenza Vaccination in Adults Over 65.

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