Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly

Study Overview
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Brief Summary
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To asses the effect of the probiotic and influenza vaccination alone and combination on enhancing immune response to influenza-like illness (ILI) and reducing ILI incidence in the elderly

Detailed Description
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To see percetange of subjects seroconvertion and seroprotection before and after intervention in the elderly (>60 years), and monitored for 6 months.

Official Title
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Role of Probiotic and Influenza Vaccination on Immune Response Enchancement and Influenza-Like Illness Incidence Reduction in Elderly

Conditions
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Influenza-like Illness

Intervention / Treatment
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* Biological: Flubio
* Dietary Supplement: Lacidofil
* Other: Placebo Vaccine
* Other: Placebo probiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all health elderly aged ≥ 60 years who came to the vaccination and health education activities in the entire East Jakarta District Health Center with Body Mass Index (BMI) 17,5-29,9 healthy mental status (MMSE score of 28-30) Exclusion Criteria: subject who have contraindications to influenza vaccinations are undergoing treatment related to immune system modulation in the past 4 weeks therapy for immunossuppresants and/ or corticosteroids eqivalent to prednisone ≥ 20 mg/day that is being lived more than 2 weeks or has only been stopped less than 3 months before the study recieved influenza vaccination less than one year before Currently consuming probiotic agents, either in the form of a manufacturer or natural for more than 7 days.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccine<br>Flubio (A/California/7/2009, A/Texas/50/2012 and B/Massachusetts/2/2012) Vaccine 0,5 ml for every subjects The vaccine will be given intramuscularly | Biological: Flubio<br>* Flubio (A/California/7/2009, A/Texas/50/2012 and B/Massachusetts/2/2012) Vaccine 0,5 ml for every subjects The vaccine will be given intramuscularly<br>|
| Experimental: Probiotic<br>Lacidofil (Lactobacillus acidophilus Rossel-52 and Lactobacillus rhamnosus Rosell-11 with maltodextrin 211 mg, magnesium stearat 8 mg and ascorbic acid 1 mg) antibiotic | Dietary Supplement: Lacidofil<br>* Lacidofil (Lactobacillus acidophilus Rossel-52 and Lactobacillus rhamnosus Rosell-11 with maltodextrin 211 mg, magnesium stearat 8 mg and ascorbic acid 1 mg) antibiotic The antibiotic will be given 2 times each day for 6 months<br>|
| Placebo Comparator: Placebo Vaccine<br>Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly | Other: Placebo Vaccine<br>* Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly<br>|
| Placebo Comparator: Placebo probiotic<br>capsul | Other: Placebo probiotic<br>* Capsul<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with anti HI titer >=1:40 | Describe seroprotection on 4-weeks, 4-months, and 6-months after interventions in elderly | 6 months | 
| Percentage subjects with increasing antibody titer >=4 times | Describe seroconvertion on 4-weeks, 4-months, and 6-months after interventions in elderly | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Vaccine, Probiotic, Influenza-like Illness