NCT03695432

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
910

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

September 28, 2018

Last Update Submit

October 3, 2018

Conditions

Influenza-like Illness

Keywords

InfluenzaVaccineProbioticInfluenza-like Illness

Outcome Measures

Primary Outcomes (1)

  • The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination

    6 months

Secondary Outcomes (2)

  • Percentage of subjects with anti HI titer >=1:40

    6 months

  • Percentage subjects with increasing antibody titer >=4 times

    6 months

Study Arms (4)

Vaccine

EXPERIMENTAL

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

Probiotic

EXPERIMENTAL

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

Placebo Vaccine

PLACEBO COMPARATOR

Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly

Other: Placebo Vaccine

Placebo probiotic

PLACEBO COMPARATOR

capsul

Other: Placebo probiotic

Interventions

FlubioBIOLOGICAL

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

Vaccine
LacidofilDIETARY_SUPPLEMENT

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

Probiotic
Placebo VaccineOTHER

Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly

Placebo Vaccine
Placebo probioticOTHER

Capsul

Placebo probiotic

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrated Health Post, at Pulo Gadung District

Jakarta, DKI Jakarta, 13310, Indonesia

Location

Related Publications (1)

  • 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.

    PMID: 34914726DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Sukamto Koesnoe, MD

    Division of Allergic and Imunologic, Department of Internal Medicine, Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 4, 2018

Study Start

October 1, 2014

Primary Completion

April 1, 2015

Study Completion

July 1, 2016

Last Updated

October 5, 2018

Record last verified: 2018-10

Locations

ID(1)