Common ColdEPIARRNCT01669603
Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)
A study testing Bifidobacterium lactis Bl-04 and Rhinovirus in people with Common Cold, run by University of Virginia at 1 site in United States.
Trial summary
The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive host responses to rhinovirus infection. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- Bifidobacterium lactis Bl-04 and Rhinovirus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 789 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- AT ENROLLMENT:
- Subject must be 18-60 years of age.
- Subject must read and sign a copy of the approved Consent Form
- Female subjects must be using an effective birth control method.
- Subject must read and sign a copy of the approved Consent Form
- AT CHALLENGE:
- Female subjects must be using an effective birth control method.
- Subject must have a serum neutralizing antibody titer of less than or equal to 1:4 to rhinovirus type 39
Who cannot join
- AT ENROLLMENT:
- Current cancer diagnosis or immunosuppressive therapy in the last 6 months
- Any clinically significant abnormalities of the upper respiratory tract
- Any clinically significant acute or chronic respiratory illness
- Any clinically significant bleeding tendency by history
- Hypertension that requires treatment with antihypertensive medications
Show all 16Show fewer
- History of angina or other clinically significant cardiac disease
- Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study
- History of regular use (more than 3 days in 7) of tobacco products within the preceding two weeks
- History of drug or alcohol abuse in the 6 months preceding the study
- Antibiotic use within 3 months prior to study start
- Female subjects with a positive urine pregnancy screen.
- History of use of probiotics in the preceding 2 weeks.
- Any upper respiratory infection or allergic rhinitis in the two weeks prior to the start of the study
- Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study
- Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold preparation in the two weeks prior to the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive host responses to rhinovirus infection.
Read the detailed description
The common cold is a ubiquitous illness of man that is associated with significant medical and socioeconomic consequences. Current treatments for the common cold that have proven efficacy are limited to pharmacologic agents that are directed at specific symptoms. These treatments- antihistamines, nasal decongestants and analgesics- have limited effectiveness, generally relieving the target symptom by 15-25% at the peak of activity, and are associated with bothersome side effects. There are no currently effective treatments for prevention of rhinovirus infections.
Probiotics have been defined by FAO/WHO as "Live microorganisms which when administered in adequate amount confer a health benefit on a host." The most common probiotics belong to Lactobacillus or Bifidobacterium genera. Bifidobacteria are natural human gut inhabitants that were discovered over a hundred years ago from the feces of breast-fed infants. The study product Bifidobacterium animalis subspecies (subsp.) lactis Bl-04 (Bl-04) has been genetically characterized as B. animalis subsp. lactis by 16S rRNA gene sequencing and full genome sequence comparison. Bl-04 has been deposited in the American Type Culture Collections safe deposit as SD5219.
This study will test the hypothesis that ingestion of a probiotic Bifidobacterium animalis subsp. lactis Bl-04 will alter the innate and adaptive host response to rhinovirus infection.
- Conditions
- Common Cold
- Being tested
- Bifidobacterium lactis Bl-04, Placebo, Rhinovirus
- Keywords
- Common cold
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium lactis Bl-04Dietary supplement
The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.
PlaceboDietary supplement
Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
RhinovirusBiological
rhinovirus for experimental challenge
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium animalis lactis Bl-04 | Experimental | Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink. Receives: Dietary Supplement: Bifidobacterium lactis Bl-04; Biological: Rhinovirus |
| Placebo | Placebo comparator | Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product. Receives: Dietary Supplement: Placebo; Biological: Rhinovirus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-8 (IL-8)
Nasal lavage will be performed to collect and measure IL-8.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 789 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- DuPont Nutrition and Health
- Responsible party
- Principal investigator, Ronald Turner, MD, University of Virginia
- Investigators
- Ronald Turner, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669603
- Sponsor's protocol ID
- 16241
- Acronym
- EPIARR
- Status last verified
- Apr 2017
- First submitted
- 16 Aug 2012
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Turner RB, Woodfolk JA, Borish L, Steinke JW, Patrie JT, Muehling LM, Lahtinen S, Lehtinen MJ. Effect of probiotic on innate inflammatory response and viral shedding in experimental rhinovirus infection - a randomised controlled trial. Benef Microbes. 2017 Apr 26;8(2):207-215. doi: 10.3920/BM2016.0160. Epub 2017 Mar 27.
PubMed 28343401
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic on the Innate and Adaptive Host Response to Rhinovirus (EPIARR)
- ClinicalTrials.gov ID
- NCT01669603
- Acronym / sponsor ID
- EPIARR / 16241
- Conditions
- Common Cold
- Keywords
- Common cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 789 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- DuPont Nutrition and Health
- Study start
- Aug 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to assess the effect of ingestion of a probiotic on innate and adaptive host responses to rhinovirus infection.
Detailed description
The common cold is a ubiquitous illness of man that is associated with significant medical and socioeconomic consequences. Current treatments for the common cold that have proven efficacy are limited to pharmacologic agents that are directed at specific symptoms. These treatments- antihistamines, nasal decongestants and analgesics- have limited effectiveness, generally relieving the target symptom by 15-25% at the peak of activity, and are associated with bothersome side effects. There are no currently effective treatments for prevention of rhinovirus infections.
Probiotics have been defined by FAO/WHO as "Live microorganisms which when administered in adequate amount confer a health benefit on a host." The most common probiotics belong to Lactobacillus or Bifidobacterium genera. Bifidobacteria are natural human gut inhabitants that were discovered over a hundred years ago from the feces of breast-fed infants. The study product Bifidobacterium animalis subspecies (subsp.) lactis Bl-04 (Bl-04) has been genetically characterized as B. animalis subsp. lactis by 16S rRNA gene sequencing and full genome sequence comparison. Bl-04 has been deposited in the American Type Culture Collections safe deposit as SD5219.
This study will test the hypothesis that ingestion of a probiotic Bifidobacterium animalis subsp. lactis Bl-04 will alter the innate and adaptive host response to rhinovirus infection.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium animalis lactis Bl-04 | Experimental | Dietary Supplement: Bifidobacterium lactis Bl-04, Biological: RhinovirusBifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Biological: RhinovirusPlacebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject must be 18-60 years of age.
- Subject must read and sign a copy of the approved Consent Form
- Female subjects must be using an effective birth control method.
- Subject must read and sign a copy of the approved Consent Form
- Female subjects must be using an effective birth control method.
Key exclusion criteria (16 listed)
- Current cancer diagnosis or immunosuppressive therapy in the last 6 months
- Any clinically significant abnormalities of the upper respiratory tract
- Any clinically significant acute or chronic respiratory illness
- Any clinically significant bleeding tendency by history
- Hypertension that requires treatment with antihypertensive medications
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 |
|---|---|---|
| Bifidobacterium lactis Bl-04The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier. | Dietary supplement | Bifidobacterium animalis lactis Bl-04 |
| PlaceboPlacebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product. | Dietary supplement | Placebo |
| Rhinovirusrhinovirus for experimental challenge | Biological | Bifidobacterium animalis lactis Bl-04, Placebo |
Primary outcome
Interleukin-8 (IL-8)
Time frame: 72 hours
Nasal lavage will be performed to collect and measure IL-8.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28343401Turner RB, Woodfolk JA, Borish L, Steinke JW, Patrie JT, Muehling LM, Lahtinen S, Lehtinen MJ. Effect of probiotic on innate inflammatory response and viral shedding in experimental rhinovirus infection - a randomised controlled trial. Benef Microbes. 2017 Apr 26;8(2):207-215. doi: 10.3920/BM2016.0160. Epub 2017 Mar 27.
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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.
Ronald Turner, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium lactis Bl-04 and Rhinovirus in people with Common Cold, run by University of Virginia 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 8 inclusion and 16 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 25 Apr 2017. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Interleukin-8 (IL-8) (time frame: 72 hours). 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 NCT01669603, 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 25 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.