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

NCT03167593 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2017-05-30

No results posted yet for this study

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.

Conditions

  • Influenza Vaccination
  • Immune Response
  • Probiotics

Interventions

DIETARY_SUPPLEMENT

Lactobacillus coryniformis K8 CECT5711

Lactobacillus coryniformis CECT5711

OTHER

Control placebo

Maltodextrin

Sponsors & Collaborators

  • Biosearch S.A.

    lead INDUSTRY

Principal Investigators

  • Carlos Gracián, MD · Hospital de San Rafael, Granada (Spain)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2016-01-07
Completion
2016-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03167593 on ClinicalTrials.gov