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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 28, 2018
First Posted Date  ICMJE October 4, 2018
Last Update Posted Date October 5, 2018
Actual Study Start Date  ICMJE October 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03695432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2018)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly
Official Title  ICMJE Role of Probiotic and Influenza Vaccination on Immune Response Enchancement and Influenza-Like Illness Incidence Reduction in Elderly
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza-like Illness
Intervention  ICMJE
  • 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
  • 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
  • Other: Placebo Vaccine
    Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
  • Other: Placebo probiotic
    Capsul
Study Arms  ICMJE
  • 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
    Intervention: Biological: Flubio
  • 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
    Intervention: Dietary Supplement: Lacidofil
  • Placebo Comparator: Placebo Vaccine
    Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
    Intervention: Other: Placebo Vaccine
  • Placebo Comparator: Placebo probiotic
    capsul
    Intervention: Other: Placebo probiotic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2018)
910
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03695432
Other Study ID Numbers  ICMJE Vaccine2016
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sukamto Koesnoe, Indonesia University
Study Sponsor  ICMJE Indonesia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sukamto Koesnoe, MD Division of Allergic and Imunologic, Department of Internal Medicine, Indonesia University
PRS Account Indonesia University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP