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

NCT03695432 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 910

Last updated 2018-10-05

No results posted yet for this study

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

Conditions

  • Influenza-like Illness

Interventions

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

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Sukamto Koesnoe, MD · Division of Allergic and Imunologic, Department of Internal Medicine, Indonesia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-04-30
Completion
2016-07-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03695432 on ClinicalTrials.gov