Influenza VaccinationPhase 2NCT03167593
Effects of Lactobacillus Coryniformis CECT5711 on Immune Response to Influenza Vaccination in Adults Over 65.
A Phase 2 study testing Lactobacillus coryniformis K8 CECT5711 in people with Influenza Vaccination and Immune Response, run by Biosearch S.A..
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccination, Immune Response, Probiotics
- What is being tested?
- Lactobacillus coryniformis K8 CECT5711
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 30 Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Residents in nursing home aged more than 65 years
Who cannot join
- Frequent gastrointestinal diseases, antibiotic treatment during the intervention, allergy to any groups of antibiotics, egg proteins or adjuvants and excipients of the flu vaccine
About this study
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.
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.
Read the 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.
- Conditions
- Influenza Vaccination, Immune Response, Probiotics
- Being tested
- Lactobacillus coryniformis K8 CECT5711, Control placebo
- Keywords
- Lactobacillus coryniformis, Flu, Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus coryniformis K8 CECT5711Dietary supplement
Also called Probiotic group
Lactobacillus coryniformis CECT5711
Control placeboOther
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Capsules containing 300 mg of maltodextrin. Receives: Other: Control placebo |
| Probiotic | Experimental | Capsules containing 3x10(9) colon-forming units of the strain L. coryniformis K8 CECT5711 in a matrix of maltodextrin. Receives: Dietary Supplement: Lactobacillus coryniformis K8 CECT5711 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (1)
Incidence of influenza-like illness
Number of cases of influenza-like illness during the follow-up period (5 months)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Oct 2015
- Primary completion7 Jan 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Gracián, MD, Principal investigator, Hospital de San Rafael, Granada (Spain)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167593
- Sponsor's protocol ID
- P039
- Status last verified
- May 2017
- First submitted
- 23 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03167593
- Acronym / sponsor ID
- P039
- Conditions
- Influenza Vaccination, Immune Response, Probiotics
- Keywords
- Lactobacillus coryniformis, Flu, Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2015
- Primary completion
- 7 Jan 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Control placeboCapsules containing 300 mg of maltodextrin. |
| Probiotic | Experimental | Dietary Supplement: Lactobacillus coryniformis K8 CECT5711Capsules containing 3x10(9) colon-forming units of the strain L. coryniformis K8 CECT5711 in a matrix of maltodextrin. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Residents in nursing home aged more than 65 years
Key exclusion criteria (1 listed)
- Frequent gastrointestinal diseases, antibiotic treatment during the intervention, allergy to any groups of antibiotics, egg proteins or adjuvants and excipients of the flu vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus coryniformis K8 CECT5711Also: Probiotic groupLactobacillus coryniformis CECT5711 | Dietary supplement | Probiotic |
| Control placeboMaltodextrin | Other | Control |
Primary outcome
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.
1 secondary outcome
Incidence of influenza-like illness
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Gracián, MD principal investigator
Hospital de San Rafael, Granada (Spain)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus coryniformis K8 CECT5711 in people with Influenza Vaccination and Immune Response, run by Biosearch S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of seroconversion (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.