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Completed

NCT Number: NCT03167593

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

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.

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Key information

Conditions

Influenza Vaccination Immune Response Infections Influenza, Human Orthomyxoviridae Infections Probiotics RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus coryniformis K8 CECT5711

Dietary Supplement

Lactobacillus coryniformis CECT5711

Other names: Probiotic group

Control placebo

Other

Maltodextrin

Primary outcomes

  1. Percentage of seroconversion

    Time frame: 2 months

    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 outcomes

  1. Incidence of influenza-like illness

    Time frame: 5 months

    Number of cases of influenza-like illness during the follow-up period (5 months)

Other outcomes

  1. Cytokines

    Time frame: 3 months

    Interleukin-10, interleukin-4, tumor necrosis factor -alpha

  2. Immunoglobulins

    Time frame: 3 months

    Immunoglobulin A (IgA) and Immunoglobulin G (IgG)

  3. Gastrointestinal manifestations

    Time frame: 5 months

    Nausea, vomits and lack of appetite during follow-up period

  4. Medication

    Time frame: 5 months

    Consumption of analgesics and antibiotics during follow-up period

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 30, 2017
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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