Respiratory Tract Infections [C08.730]Phase 4NCT01229917
Rhinovirus Study With Lactobacillus Rhamnosus GG
A Phase 4 study testing Fruit juice with Lactobacillus rhamnosus GG, version 1, Fruit juice with Lactobacillus rhamnosus GG, version 2 and Standard fruit juice in people with Respiratory Tract Infections [C08.730], run by Valio Ltd at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus rhamnosus GG during rhinovirus infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Respiratory Tract Infections [C08.730]
- What is being tested?
- Fruit juice with Lactobacillus rhamnosus GG, version 1, Fruit juice with Lactobacillus rhamnosus GG, version 2 and Standard fruit juice
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female in general good health (stabilized chronic illnesses and regular medications are accepted, if not otherwise mentioned in the exclusion criteria)
- Age 18-65 years
- Serum neutralizing antibody titer of 1:4 or less for the challenge rhinovirus
- No clinically significant finding on the pre-study nasal examination
- Females must have a negative urine pregnancy test, and women of child-bearing potential must be using an effective method of birth control such as, but not limited to birth control pills, contraceptive foam, diaphragm, IUD, surgical sterilization, abstinence, or condoms
- Written informed consent must be obtained at enrollment into the study
Who cannot join
- Suffer from or have a history of significant allergic rhinitis at the time of study
- Bronchial asthma or other lower respiratory tract diseases, such as chronic obstructive lung disease or emphysema
- Nasal abnormalities or other nasal pathology, such as irreversible nasal mucosal hypertrophy or severe nasal septum derivation
- Pregnancy or lactation
- History of alcohol abuse (regularly consumes 5 or more alcohol drinks per day) and/or drug abuse during the 12 month period immediately preceding study enrollment
- Daily smoking within the past 2 years
Show all 10Show fewer
- Use of investigational product or participation in a device trial during the 30 day period immediately preceding study enrollment
- Previous participation in an experimental study with rhinovirus 39
- Allergy to any ingredient in the study product
- Have, as determined by the investigator and/or the sponsor's medical monitor, any surgical or medical condition or take any medication or dietary supplement that could interfere with the interpretation of study results or jeopardize the safety of the subject
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia, Respiratory Disease Study Center
Charlottesville, Virginia
About this study
The purpose of this study is to evaluate the symptom impact of probiotic Lactobacillus rhamnosus GG during rhinovirus infection.
- Conditions
- Respiratory Tract Infections [C08.730]
- Being tested
- Fruit juice with Lactobacillus rhamnosus GG, version 1, Fruit juice with Lactobacillus rhamnosus GG, version 2, Standard fruit juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruit juice with Lactobacillus rhamnosus GG, version 1Other
Fruit juice with Lactobacillus rhamnosus GG, version 2Other
Standard fruit juiceOther
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract Infections [C08.730]Studies 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
Sponsor and investigators
- Lead sponsor
- Valio Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, University of Virginia, Medcare Ltd
- Investigators
- Birgit Winther, Dr., Principal investigator, University of Virginia Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229917
- Sponsor's protocol ID
- Valio-73
- Status last verified
- Jul 2011
- First submitted
- 26 Oct 2010
- Last updated
- 7 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhinovirus Study With Lactobacillus Rhamnosus GG
- ClinicalTrials.gov ID
- NCT01229917
- Acronym / sponsor ID
- Valio-73
- Conditions
- Respiratory Tract Infections [C08.730]
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Valio LtdIndustry (pharma, biotech, devices)
- Collaborators
- University of Helsinki, University of Virginia, Medcare Ltd
- First posted
- 28 Oct 2010 (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 evaluate the symptom impact of probiotic Lactobacillus rhamnosus GG during rhinovirus infection.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female in general good health (stabilized chronic illnesses and regular medications are accepted, if not otherwise mentioned in the exclusion criteria)
- Age 18-65 years
- Serum neutralizing antibody titer of 1:4 or less for the challenge rhinovirus
- No clinically significant finding on the pre-study nasal examination
- Females must have a negative urine pregnancy test, and women of child-bearing potential must be using an effective method of birth control such as, but not limited to birth control pills, contraceptive foam, diaphragm, IUD, surgical sterilization, abstinence, or condoms
Key exclusion criteria (10 listed)
- Suffer from or have a history of significant allergic rhinitis at the time of study
- Bronchial asthma or other lower respiratory tract diseases, such as chronic obstructive lung disease or emphysema
- Nasal abnormalities or other nasal pathology, such as irreversible nasal mucosal hypertrophy or severe nasal septum derivation
- Pregnancy or lactation
- History of alcohol abuse (regularly consumes 5 or more alcohol drinks per day) and/or drug abuse during the 12 month period immediately preceding study enrollment
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 |
|---|---|---|
| Fruit juice with Lactobacillus rhamnosus GG, version 1 | Other | – |
| Fruit juice with Lactobacillus rhamnosus GG, version 2 | Other | – |
| Standard fruit juice | Other | – |
Primary outcome
Not reported in the source record.
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 7 Jul 2011.
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.
Birgit Winther, Dr. principal investigator
University of Virginia Health System
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 Fruit juice with Lactobacillus rhamnosus GG, version 1, Fruit juice with Lactobacillus rhamnosus GG, version 2 and Standard fruit juice in people with Respiratory Tract Infections [C08.730], run by Valio Ltd at 1 site in United States.
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 6 inclusion and 10 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 7 Jul 2011. 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 United States. 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.
Where can I read the original study information?
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 7 Jul 2011.