Upper Respiratory Tract InfectionPhase 2NCT01935986
The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children
A Phase 2 study testing probiotic in people with Upper Respiratory Tract Infection, run by Probi AB at 1 site in Sweden.
Trial summary
The purpose of this study is to study the effect of a probiotic on protection against upper respiratory tract infections (URTI) in children. Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infection
- What is being tested?
- probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 2
- 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 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to study the effect of a probiotic on protection against upper respiratory tract infections (URTI) in children.
- Conditions
- Upper Respiratory Tract Infection
- Being tested
- probiotic, placebo
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticDietary supplement
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| probiotic | Experimental | dietary supplement Receives: Dietary Supplement: probiotic |
| placebo | Placebo comparator | dietary supplement without probiotic Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper respiratory tract infections
Measured: study period, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Due to bankruptcy of the CRO company
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935986
- Sponsor's protocol ID
- U-12-032
- Status last verified
- Jan 2015
- First submitted
- 28 Aug 2013
- Last updated
- 3 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children
- ClinicalTrials.gov ID
- NCT01935986
- Acronym / sponsor ID
- U-12-032
- Conditions
- Upper Respiratory Tract Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to bankruptcy of the CRO company
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Sep 2013 (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 study the effect of a probiotic on protection against upper respiratory tract infections (URTI) in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic | Experimental | Dietary Supplement: probioticdietary supplement |
| placebo | Placebo comparator | Dietary Supplement: placebodietary supplement without probiotic |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy children
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| probiotic | Dietary supplement | probiotic |
| placebo | Dietary supplement | placebo |
Primary outcome
upper respiratory tract infections
Time frame: study period, 12 weeks
Results and safety
The study was stopped early (reason given: Due to bankruptcy of the CRO company). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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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 2 study testing probiotic in people with Upper Respiratory Tract Infection, run by Probi AB at 1 site in Sweden.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 Dec 2015. 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 Sweden. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Due to bankruptcy of the CRO company). Results are not available in the source record.
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?
upper respiratory tract infections (time frame: study period, 12 weeks). It is what the study was designed to measure, not a finding.
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 3 Dec 2015.