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Completed

NCT Number: NCT03695432

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

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

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Key information

Conditions

Influenza-like Illness Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Integrated Health Post, at Pulo Gadung District

Jakarta, DKI Jakarta, 13310, Indonesia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flubio

Biological

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

Lacidofil

Dietary 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 Vaccine

Other

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

Placebo probiotic

Other

Capsul

Primary outcomes

  1. 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

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

    Time frame: 6 months

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

  2. Percentage subjects with increasing antibody titer >=4 times

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 4, 2018
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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