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

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

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

Study Overview

• Status: Completed
• Conditions: Influenza-like Illness
• Intervention / Treatment: Biological: Flubio; Dietary supplement: Lacidofil; Other: Placebo Vaccine; Other: Placebo probiotic

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: Interventional
• Enrollment (Actual): 910
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 13310
      • Integrated Health Post, at Pulo Gadung District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage subjects with increasing antibody titer >=4 times	Describe seroconvertion on 4-weeks, 4-months, and 6-months after interventions in elderly	6 months

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Sukamto Koesnoe, MD, Division of Allergic and Imunologic, Department of Internal Medicine, Indonesia University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): October 5, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Influenza; Vaccine; Probiotic; Influenza-like Illness
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: Vaccine2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED