Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly
Primary Purpose
Influenza-like Illness
Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Flubio
Lacidofil
Placebo Vaccine
Placebo probiotic
Sponsored by
About this trial
This is an interventional prevention trial for Influenza-like Illness focused on measuring Influenza, Vaccine, Probiotic, Influenza-like Illness
Eligibility 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.
Sites / Locations
- Integrated Health Post, at Pulo Gadung District
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Vaccine
Probiotic
Placebo Vaccine
Placebo probiotic
Arm Description
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 (Lactobacillus acidophilus Rossel-52 and Lactobacillus rhamnosus Rosell-11 with maltodextrin 211 mg, magnesium stearat 8 mg and ascorbic acid 1 mg) antibiotic
Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
capsul
Outcomes
Primary Outcome Measures
The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination
Secondary Outcome Measures
Percentage of subjects with anti HI titer >=1:40
Describe seroprotection on 4-weeks, 4-months, and 6-months after interventions in elderly
Percentage subjects with increasing antibody titer >=4 times
Describe seroconvertion on 4-weeks, 4-months, and 6-months after interventions in elderly
Full Information
NCT ID
NCT03695432
First Posted
September 28, 2018
Last Updated
October 3, 2018
Sponsor
Indonesia University
1. Study Identification
Unique Protocol Identification Number
NCT03695432
Brief Title
Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly
Official Title
Role of Probiotic and Influenza Vaccination on Immune Response Enchancement and Influenza-Like Illness Incidence Reduction in Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza-like Illness
Keywords
Influenza, Vaccine, Probiotic, Influenza-like Illness
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
910 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccine
Arm Type
Experimental
Arm Description
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
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Lacidofil (Lactobacillus acidophilus Rossel-52 and Lactobacillus rhamnosus Rosell-11 with maltodextrin 211 mg, magnesium stearat 8 mg and ascorbic acid 1 mg) antibiotic
Arm Title
Placebo Vaccine
Arm Type
Placebo Comparator
Arm Description
Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
Arm Title
Placebo probiotic
Arm Type
Placebo Comparator
Arm Description
capsul
Intervention Type
Biological
Intervention Name(s)
Flubio
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Lacidofil
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo Vaccine
Intervention Description
Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
Intervention Type
Other
Intervention Name(s)
Placebo probiotic
Intervention Description
Capsul
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Percentage of subjects with anti HI titer >=1:40
Description
Describe seroprotection on 4-weeks, 4-months, and 6-months after interventions in elderly
Time Frame
6 months
Title
Percentage subjects with increasing antibody titer >=4 times
Description
Describe seroconvertion on 4-weeks, 4-months, and 6-months after interventions in elderly
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sukamto Koesnoe, MD
Organizational Affiliation
Division of Allergic and Imunologic, Department of Internal Medicine, Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrated Health Post, at Pulo Gadung District
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
13310
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34914726
Citation
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.
Results Reference
derived
Learn more about this trial
Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly
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