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

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ClinicalTrials.gov Identifier: NCT03695432
Recruitment Status : Completed
First Posted : October 4, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Sukamto Koesnoe, Indonesia University

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

Condition or disease Intervention/treatment Phase
Influenza-like Illness Biological: Flubio Dietary Supplement: Lacidofil Other: Placebo Vaccine Other: Placebo probiotic Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 910 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Probiotic and Influenza Vaccination on Immune Response Enchancement and Influenza-Like Illness Incidence Reduction in Elderly
Actual Study Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Vaccine
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
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

Experimental: Probiotic
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
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 Comparator: Placebo Vaccine
Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
Other: Placebo Vaccine
Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly

Placebo Comparator: Placebo probiotic
capsul
Other: Placebo probiotic
Capsul




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695432


Locations
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Indonesia
Integrated Health Post, at Pulo Gadung District
Jakarta, DKI Jakarta, Indonesia, 13310
Sponsors and Collaborators
Indonesia University
Investigators
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Principal Investigator: Sukamto Koesnoe, MD Division of Allergic and Imunologic, Department of Internal Medicine, Indonesia University

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Responsible Party: Sukamto Koesnoe, Principal investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT03695432     History of Changes
Other Study ID Numbers: Vaccine2016
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sukamto Koesnoe, Indonesia University:
Influenza
Vaccine
Probiotic
Influenza-like Illness
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs