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

University of Indonesia (UI)

Status and phase: Completed; Phase 4

Conditions: Influenza-like Illness

Treatments: Other: Placebo probiotic; Biological: Flubio; Other: Placebo Vaccine; Dietary Supplement: Lacidofil

Study type: Interventional

Funder types: Other

Identifiers

NCT03695432

Vaccine2016

Details and patient eligibility

About

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

Full description

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

Enrollment: 910 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

910 participants in 4 patient groups, including a placebo group

Vaccine

Experimental group

Description:

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

Treatment:

Biological: Flubio

Probiotic

Experimental group

Description:

Lacidofil (Lactobacillus acidophilus Rossel-52 and Lactobacillus rhamnosus Rosell-11 with maltodextrin 211 mg, magnesium stearat 8 mg and ascorbic acid 1 mg) antibiotic

Treatment:

Dietary Supplement: Lacidofil

Placebo Vaccine

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo Vaccine

Placebo probiotic

Placebo Comparator group

Description:

capsul

Treatment:

Other: Placebo probiotic