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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
To see percetange of subjects seroconvertion and seroprotection before and after intervention in the elderly (>60 years), and monitored for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Placebo Vaccine | Placebo Comparator | Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly |
|
| Placebo probiotic | Placebo Comparator | capsul |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flubio | Biological | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sukamto Koesnoe, MD | Division of Allergic and Imunologic, Department of Internal Medicine, Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrated Health Post, at Pulo Gadung District | Jakarta | DKI Jakarta | 13310 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34914726 | Derived | 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. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Lacidofil | Dietary 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 |
|
| Placebo Vaccine | Other | Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly |
|
| Placebo probiotic | Other | Capsul |
|
Describe seroconvertion on 4-weeks, 4-months, and 6-months after interventions in elderly
| 6 months |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |