Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly
NCT ID: NCT03695432
Last Updated: 2018-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
910 participants
INTERVENTIONAL
2014-10-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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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
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
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
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 Vaccine
Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
Placebo Vaccine
Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
Placebo probiotic
capsul
Placebo probiotic
Capsul
Interventions
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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
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 Vaccine
Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
Placebo probiotic
Capsul
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
90 Years
ALL
Yes
Sponsors
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Indonesia University
OTHER
Responsible Party
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Sukamto Koesnoe
Principal investigator
Principal Investigators
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Sukamto Koesnoe, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Allergic and Imunologic, Department of Internal Medicine, Indonesia University
Locations
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Integrated Health Post, at Pulo Gadung District
Jakarta, DKI Jakarta, Indonesia
Countries
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References
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Koesnoe S, Masjkuri N, Adisasmita A, Djauzi S, Kartasasmita C, Sundoro J, Nadjib M, Korib M, Muthia AN, Muzellina VN, Habibah U, Nursyirwan SA, Djaya KH, Bachtiar NS, Sari RM. A randomized controlled trial to evaluate the effect of influenza vaccination and probiotic supplementation on immune response and incidence of influenza-like illness in an elderly population in Indonesia. PLoS One. 2021 Dec 16;16(12):e0250234. doi: 10.1371/journal.pone.0250234. eCollection 2021.
Other Identifiers
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Vaccine2016
Identifier Type: -
Identifier Source: org_study_id
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