Respiratory Tract InfectionsPhase 4NCT00849277
Study of the Effect of Probiotics on Respiratory Morbidity After Influenza Vaccination of Elderly in Nursing Homes
A Phase 4 study testing Lactobacillus casei Shirota in people with Respiratory Tract Infections, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
The purpose of this study is to determine whether probiotic treatment improves the protection against respiratory infections after influenza vaccination in elderly living in nursing homes. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- Lactobacillus casei Shirota
- How many people
- 737 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2006to Apr 2008
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- healthy male and female volunteers of 65 years or older
- volunteers reside in residential homes
- volunteers must be willing to swallow Yakult/placebo 2x/day for 3 weeks prevaccination and 5 months follow-up
- participants must be able to comply with requirements of study (e.g. assessment of respiratory symptoms, Yakult/placebo administration)
- participants must read and sign written Informed Consent Form after the nature of the study has been fully explained
Who cannot join
- elderly with:
- any medical or practical condition which make the volunteer not suitable for participating in this study at discretion of the investigator
- any current relevant infectious disease
- any current known disorder having negative repercussions on the volunteer's immune system, such as auto-immune diseases, COPD requiring oxigen, cancer, chronic inflammatory disease
- allergy to influenza vaccine, eggs, neomycin, amphotericin B, erythromycin, amantadine
- ongoing treatment with immunosuppressive drugs, chemotherapeutics or other antineoplastic medication
Show all 9Show fewer
- current use of antibiotics or use 6 weeks prior to study entry
- use of any investigative drug (other drugs who are also under investigation) within 90 days prior to study entry
- with markedly abnormal results in any of the screening laboratory tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An RCT in Nursing Homes: the Effect of a Probiotic Treatment With Lactobacillus Casei Shirota on Respiratory Morbidity After Influenza Vaccination of Elderly.
The purpose of this study is to determine whether probiotic treatment improves the protection against respiratory infections after influenza vaccination in elderly living in nursing homes.
Read the detailed description
Influenza virus is a member of the orthomyxovirus family and causes an acute viral disease of the respiratory tract. The illness is usually self-limiting. Hospitalization and deaths mainly occur in high-risk groups (elderly, chronically ill). Response to vaccination is subject to high levels of variability due to age, stress, nutritional stage, etc.
Lactic acid bacteria are naturally commensal bacteria in the small and large intestines. These bacteria protect the host against potential pathogens by competitive exclusion and also by the production of antibacterial agents known as bacteriocins. It has only been recently shown that another mechanism whereby probiotic bacteria may provide a health benefit is by modulating immune responses.
Lactobacillus casei strain Shirota (LcS) is widely consumed in fermented milk products. Several studies, in animals as wells as in humans, report on the immunomodulatory functions of LcS.
The aim of this multicentre, randomized, placebo controlled, double blind study (RCT) is to assess if probiotic treatment with Lactobacillus casei Shirota improves the protection against influenza(-like) infections after vaccination with trivalent influenza vaccine in elderly residing in nursing homes.
Trial endpoints:
- Clinical outcome: difference in incidence in upper respiratory tract infections (influenza-like illness)
- Serological outcome: difference in influenza vaccine specific serum IgG between probiotic and control treatment
- Conditions
- Respiratory Tract Infections
- Being tested
- Lactobacillus casei Shirota
- Keywords
- Respiratory Tract Infections, Influenza, Human, Probiotics
- Medical subject headings
- Respiratory Tract Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus casei ShirotaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome: difference in incidence in upper respiratory tract infections (influenza-like illness)
Measured: during 5 months
Serological outcome: difference in influenza vaccine specific serum IgG between probiotic and control treatment
Measured: 4 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startOct 2006
- Primary completionApr 2008
- Study completionApr 2008
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 Respiratory Tract InfectionsStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 737 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849277
- Sponsor's protocol ID
- 2414
- Status last verified
- Feb 2009
- First submitted
- 20 Feb 2009
- Last updated
- 23 Feb 2009
- Results posted
- No
Publications
Van Puyenbroeck K, Hens N, Coenen S, Michiels B, Beunckens C, Molenberghs G, Van Royen P, Verhoeven V. Efficacy of daily intake of Lactobacillus casei Shirota on respiratory symptoms and influenza vaccination immune response: a randomized, double-blind, placebo-controlled trial in healthy elderly nursing home residents. Am J Clin Nutr. 2012 May;95(5):1165-71. doi: 10.3945/ajcn.111.026831. Epub 2012 Mar 21.
PubMed 22440853
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT in Nursing Homes: the Effect of a Probiotic Treatment With Lactobacillus Casei Shirota on Respiratory Morbidity After Influenza Vaccination of Elderly.
- ClinicalTrials.gov ID
- NCT00849277
- Acronym / sponsor ID
- 2414
- Conditions
- Respiratory Tract Infections
- Keywords
- Respiratory Tract Infections, Influenza, Human, Probiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 737 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Study start
- Oct 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 23 Feb 2009 (estimated)
- 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.
The purpose of this study is to determine whether probiotic treatment improves the protection against respiratory infections after influenza vaccination in elderly living in nursing homes.
Detailed description
Influenza virus is a member of the orthomyxovirus family and causes an acute viral disease of the respiratory tract. The illness is usually self-limiting. Hospitalization and deaths mainly occur in high-risk groups (elderly, chronically ill). Response to vaccination is subject to high levels of variability due to age, stress, nutritional stage, etc.
Lactic acid bacteria are naturally commensal bacteria in the small and large intestines. These bacteria protect the host against potential pathogens by competitive exclusion and also by the production of antibacterial agents known as bacteriocins. It has only been recently shown that another mechanism whereby probiotic bacteria may provide a health benefit is by modulating immune responses.
Lactobacillus casei strain Shirota (LcS) is widely consumed in fermented milk products. Several studies, in animals as wells as in humans, report on the immunomodulatory functions of LcS.
The aim of this multicentre, randomized, placebo controlled, double blind study (RCT) is to assess if probiotic treatment with Lactobacillus casei Shirota improves the protection against influenza(-like) infections after vaccination with trivalent influenza vaccine in elderly residing in nursing homes.
Trial endpoints:
- Clinical outcome: difference in incidence in upper respiratory tract infections (influenza-like illness)
- Serological outcome: difference in influenza vaccine specific serum IgG between probiotic and control treatment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- healthy male and female volunteers of 65 years or older
- volunteers reside in residential homes
- volunteers must be willing to swallow Yakult/placebo 2x/day for 3 weeks prevaccination and 5 months follow-up
- participants must be able to comply with requirements of study (e.g. assessment of respiratory symptoms, Yakult/placebo administration)
- participants must read and sign written Informed Consent Form after the nature of the study has been fully explained
Key exclusion criteria (9 listed)
- any medical or practical condition which make the volunteer not suitable for participating in this study at discretion of the investigator
- any current relevant infectious disease
- any current known disorder having negative repercussions on the volunteer's immune system, such as auto-immune diseases, COPD requiring oxigen, cancer, chronic inflammatory disease
- allergy to influenza vaccine, eggs, neomycin, amphotericin B, erythromycin, amantadine
- ongoing treatment with immunosuppressive drugs, chemotherapeutics or other antineoplastic medication
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 |
|---|---|---|
| Lactobacillus casei Shirota | Drug | – |
Primary outcome
Clinical outcome: difference in incidence in upper respiratory tract infections (influenza-like illness)
Time frame: during 5 months
Serological outcome: difference in influenza vaccine specific serum IgG between probiotic and control treatment
Time frame: 4 weeks after vaccination
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 23 Feb 2009.
- Derived from this study: PubMed 22440853Van Puyenbroeck K, Hens N, Coenen S, Michiels B, Beunckens C, Molenberghs G, Van Royen P, Verhoeven V. Efficacy of daily intake of Lactobacillus casei Shirota on respiratory symptoms and influenza vaccination immune response: a randomized, double-blind, placebo-controlled trial in healthy elderly nursing home residents. Am J Clin Nutr. 2012 May;95(5):1165-71. doi: 10.3945/ajcn.111.026831. Epub 2012 Mar 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lactobacillus casei Shirota in people with Respiratory Tract Infections, run by Universiteit Antwerpen at 1 site in Belgium.
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 5 inclusion and 9 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 23 Feb 2009. 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 Belgium. 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. 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?
Clinical outcome: difference in incidence in upper respiratory tract infections (influenza-like illness) (time frame: during 5 months). The study lists 2 primary outcomes in all. 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 NCT00849277, 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 23 Feb 2009.