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

• Sponsor: Biosearch S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03167593
• Collaborator: (none)
• Enrollment: 98
• Arms: 2
• Duration (Months): 7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza Vaccination; Immune Response; Probiotics	Dietary Supplement: Lactobacillus coryniformis K8 CECT5711; Other: Control placebo	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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 Start Date: Oct 1, 2015
• Actual Primary Completion Date: Jan 7, 2016
• Actual Study Completion Date: Apr 30, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of seroconversion [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 Outcome Measures

1. Incidence of influenza-like illness [5 months]

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

Other Outcome Measures

1. Cytokines [3 months]

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

2. Immunoglobulins [3 months]

   Immunoglobulin A (IgA) and Immunoglobulin G (IgG)

3. Gastrointestinal manifestations [5 months]

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

4. Medication [5 months]

   Consumption of analgesics and antibiotics during follow-up period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Biosearch S.A.

Investigators

• Principal Investigator: Carlos Gracián, MD, Hospital de San Rafael, Granada (Spain)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biosearch S.A.
• ClinicalTrials.gov Identifier: NCT03167593
• Other Study ID Numbers: P039
• First Posted: May 30, 2017
• Last Update Posted: May 30, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Biosearch S.A.: Lactobacillus coryniformis; Flu; Vaccine
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of May 30, 2017