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

Universitas Indonesia910 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

910

Conditions

Influenza-like Illness

Interventions

FlubioBIOLOGICAL

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

LacidofilDIETARY_SUPPLEMENT

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

Placebo VaccineOTHER

Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly

Eligibility

Sex: ALLMin age: 60 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Integrated Health Post, at Pulo Gadung District

Jakarta, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination

Time frame: 6 months

Secondary Outcomes

Percentage of subjects with anti HI titer >=1:40

Describe seroprotection on 4-weeks, 4-months, and 6-months after interventions in elderly

Time frame: 6 months

Percentage subjects with increasing antibody titer >=4 times

Describe seroconvertion on 4-weeks, 4-months, and 6-months after interventions in elderly

Time frame: 6 months

Data from ClinicalTrials.gov

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