Influenza-like IllnessPhase 4NCT03695432

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

A Phase 4 study testing Flubio and Lacidofil in people with Influenza-like Illness, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 60 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Influenza-like Illness
What is being tested?: Flubio and Lacidofil
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 910 participants
Where: 1 siteIndonesia
Study dates: Oct 2014to Jul 2016
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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 locations and contacts

1 site in 1 country.

Indonesia1 site

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

Other trials in Indonesia

About this study

Official title: 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

Read the detailed description

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

Conditions: Influenza-like Illness
Being tested: Flubio, Lacidofil, Placebo Vaccine, Placebo probiotic
Keywords: Influenza, Vaccine, Probiotic, Influenza-like Illness
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
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
Placebo VaccineOther
Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
Placebo probioticOther
Capsul

Study groups in NCT03695432
Study group	Role	What they receive
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 Receives: 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 Receives: Dietary Supplement: Lacidofil
Placebo Vaccine	Placebo comparator	Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly Receives: Other: Placebo Vaccine
Placebo probiotic	Placebo comparator	capsul Receives: Other: Placebo probiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Percentage of subjects with anti HI titer >=1:40
Describe seroprotection on 4-weeks, 4-months, and 6-months after interventions in elderly
Measured: 6 months
Percentage subjects with increasing antibody titer >=4 times
Describe seroconvertion on 4-weeks, 4-months, and 6-months after interventions in elderly
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Jul 2016

First posted4 Oct 2018
Study startOct 2014
Primary completionApr 2015
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Influenza-like IllnessStudies of the same condition, open and under way.
More trials run by Universitas IndonesiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 910 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03695432
Sponsor's protocol ID: Vaccine2016
Status last verified: Oct 2018
First submitted: 28 Sep 2018
Last updated: 5 Oct 2018
Results posted: No
Individual data sharing: Undecided

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.
PubMed 34914726

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Mucosal and Systemic Immunity Correlates of Protection Against Influenza in Young Children, Aged 2-5 Years (MUSIC-Flu)
Influenza -Like Illness, Influenza (Healthy Volunteers)
Recruiting
Abbott ID NOW Point-of-Care Testing
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RecruitingPhase 3
A Study on the Efficacy of a Vaccine Against Influenza in Adults ≥65 Years of Age
Influenza, Human
RecruitingObservational study
Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France
Respiratory Tract Infections (RTI), Influenza -Like Illness
Recruiting
Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care
Acute Respiratory Infection, Influenza-like Illness

All Influenza-like Illness trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of Probiotic and Influenza Vaccination on Immune Response Enchancement and Influenza-Like Illness Incidence Reduction in Elderly
ClinicalTrials.gov ID: NCT03695432
Acronym / sponsor ID: Vaccine2016
Conditions: Influenza-like Illness
Keywords: Influenza, Vaccine, Probiotic, Influenza-like Illness
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 910 participants (actual)
Lead sponsor: Universitas IndonesiaUniversity, hospital or other
Study start: Oct 2014 (actual)
Primary completion: Apr 2015 (actual)
Study completion: Jul 2016 (actual)
First posted: 4 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Vaccine	Experimental	Biological: FlubioFlubio (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	Dietary Supplement: LacidofilLacidofil (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	Other: Placebo VaccineNacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
Placebo probiotic	Placebo comparator	Other: Placebo probioticcapsul

Who may qualify

Ages: 60 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FlubioFlubio (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	Vaccine
LacidofilLacidofil (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	Dietary supplement	Probiotic
Placebo VaccineNacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly	Other	Placebo Vaccine
Placebo probioticCapsul	Other	Placebo probiotic

Primary outcome

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

2 secondary outcomes

Percentage of subjects with anti HI titer >=1:40
Time frame: 6 months
Percentage subjects with increasing antibody titer >=4 times
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
Derived from this study: PubMed 34914726Koesnoe 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.
Individual participant dataSharing planned: Undecided

Related trials for Influenza-like Illness

RecruitingObservational study
Mucosal and Systemic Immunity Correlates of Protection Against Influenza in Young Children, Aged 2-5 Years (MUSIC-Flu)
Influenza -Like Illness, Influenza (Healthy Volunteers)
Recruiting
Abbott ID NOW Point-of-Care Testing
Influenza, Influenza-like Illness
RecruitingPhase 3
A Study on the Efficacy of a Vaccine Against Influenza in Adults ≥65 Years of Age
Influenza, Human
RecruitingObservational study
Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France
Respiratory Tract Infections (RTI), Influenza -Like Illness
Recruiting
Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care
Acute Respiratory Infection, Influenza-like Illness

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sukamto Koesnoe, MD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Flubio and Lacidofil in people with Influenza-like Illness, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The precentage enhancement of the immune response to flubio vaccine and probiotic compared to plasebo 6 months after vaccination (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03695432, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.