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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03695432

Enrollment

910

Registered

2018-10-04

Start date

2014-10-31

Completion date

2016-07-31

Last updated

2018-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza-like Illness

Keywords

Influenza, Vaccine, Probiotic, Influenza-like Illness

Brief summary

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

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

Interventions

BIOLOGICALFlubio

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

DIETARY_SUPPLEMENTLacidofil

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

OTHERPlacebo Vaccine

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

OTHERPlacebo probiotic

Capsul

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026