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

NCT03167593 | Completed Phase 2

• 1 other identifier: P039
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza Vaccination; Immune Response; Probiotics

Keywords

Lactobacillus coryniformis; Flu; Vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of influenza-like illness

  5 months

Other Outcomes (4)

• Cytokines

  3 months

• Immunoglobulins

  3 months

• Gastrointestinal manifestations

  5 months

Study Arms (2)

Control

PLACEBO COMPARATOR

Capsules containing 300 mg of maltodextrin.

Other: Control placebo

Probiotic

EXPERIMENTAL

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

Interventions

Lactobacillus coryniformis K8 CECT5711 DIETARY_SUPPLEMENT

Lactobacillus coryniformis CECT5711

Also known as: Probiotic group

Probiotic

Control placebo OTHER

Maltodextrin

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Residents in nursing home aged more than 65 years

You may not qualify if:

• Frequent gastrointestinal diseases, antibiotic treatment during the intervention, allergy to any groups of antibiotics, egg proteins or adjuvants and excipients of the flu vaccine

Sponsors & Collaborators

• Biosearch S.A.: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Carlos Gracián, MD

  Hospital de San Rafael, Granada (Spain)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 30, 2017
• Study Start: October 1, 2015
• Primary Completion: January 7, 2016
• Study Completion: April 30, 2016
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share