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

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.

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.

Study Overview

• Status: Completed
• Conditions: Immune Response; Probiotics; Influenza Vaccination
• Intervention / Treatment: Other: Control placebo; Dietary supplement: Lactobacillus coryniformis K8 CECT5711

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.

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Capsules containing 300 mg of maltodextrin.	Other: Control placebo; Maltodextrin
Experimental: Probiotic; Capsules containing 3x10(9) colon-forming units of the strain L. coryniformis K8 CECT5711 in a matrix of maltodextrin.	Dietary supplement: Lactobacillus coryniformis K8 CECT5711; Lactobacillus coryniformis CECT5711; Other Names: Probiotic group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of influenza-like illness	Number of cases of influenza-like illness during the follow-up period (5 months)	5 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokines	Interleukin-10, interleukin-4, tumor necrosis factor -alpha	3 months
Immunoglobulins	Immunoglobulin A (IgA) and Immunoglobulin G (IgG)	3 months
Gastrointestinal manifestations	Nausea, vomits and lack of appetite during follow-up period	5 months
Medication	Consumption of analgesics and antibiotics during follow-up period	5 months

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Investigators: Principal Investigator: Carlos Gracián, MD, Hospital de San Rafael, Granada (Spain)

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): January 7, 2016
• Study Completion (Actual): April 30, 2016

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Vaccine; Flu; Lactobacillus coryniformis
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: P039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No