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

Influenza-like Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695432
• Other study ID #: Vaccine2016
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: July 2016

Study information

• Verified date: October 2018
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 910
• Est. completion date: July 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza, Human
• Influenza-like Illness

Intervention

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
• Placebo probiotic
Capsul

Locations

Country	Name	City	State
Indonesia	Integrated Health Post, at Pulo Gadung District	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination		6 months
Secondary	Percentage of subjects with anti HI titer >=1:40	Describe seroprotection on 4-weeks, 4-months, and 6-months after interventions in elderly	6 months
Secondary	Percentage subjects with increasing antibody titer >=4 times	Describe seroconvertion on 4-weeks, 4-months, and 6-months after interventions in elderly	6 months