Personal SatisfactionNCT02011035
Evaluating the Clinical Efficacy and Safety of Colflex
An observational study of Personal Satisfaction, run by University of Manitoba at 1 site in Canada.
Trial summary
This study is designed to test the safety and efficacy of Colflex, an oral spray created by Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and sore throats, as well as dental and oral health changes. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Personal Satisfaction
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Mar 2014
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Residents in town
Who may be able to join
- availability to give written consent
- age 18-60, men and women (who are not pregnant or nursing)
- people in good health
- able to follow protocol
- must be experiencing a sore throat or cold at least once a year
Who cannot join
- smokers
- liver and kidney disease
- inflammatory bowel disease
- pancreatitis
- gallbladder or biliary disease
- neurolgical/psychological disease
Show all 15Show fewer
- bleeding disorders
- platelet abnormatilies
- gastrointestinal disorders that could interfere with fat absorption
- serum triglycerides > 500 mg/dL and/or total cholesterol > 300 mg/dL
- hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 100 Hg
- BMI >30
- consume or planned to consume anticoagulant, hypertension, or lipid lowering medications
- reported consumption of more than 2 alcoholic drinks/day or history of alcoholism or drug dependence
- reported use of experimental medication within 1 month prior to the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Clinical Efficacy and Safety of Colfelx
This study is designed to test the safety and efficacy of Colflex, an oral spray created by Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and sore throats, as well as dental and oral health changes.
- Conditions
- Personal Satisfaction
- Keywords
- Oral health, Mouth health, Halitosis, Oral bacteria, Sore throat, Colds
- Medical subject headings
- Personal Satisfaction, Halitosis, Pharyngitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and duration of colds/sore throats
Using a self-reported scale to assess the frequency and during of colds and sore throats at screening, and at baseline and endpoint of treatments
Measured: 30 days
Secondary outcomes (1)
Assessment of oral pathogenic bacteria
A mouth swab will be taken to measure pathogenic bacteria (Straph, Strep), and a mouth swab will be used for the BANA test to test for periodontal disease causing bacteria.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personal SatisfactionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Peter Jones, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011035
- Sponsor's protocol ID
- B2013:133
- Status last verified
- Mar 2015
- First submitted
- 30 Sep 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Efficacy and Safety of Colfelx
- ClinicalTrials.gov ID
- NCT02011035
- Acronym / sponsor ID
- B2013:133
- Conditions
- Personal Satisfaction
- Keywords
- Oral health, Mouth health, Halitosis, Oral bacteria, Sore throat, Colds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Dec 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.
This study is designed to test the safety and efficacy of Colflex, an oral spray created by Innotech Nutrition, on human subjects to measure changes on frequency/duration of colds and sore throats, as well as dental and oral health changes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents in town
Key inclusion criteria (5 listed)
- availability to give written consent
- age 18-60, men and women (who are not pregnant or nursing)
- people in good health
- able to follow protocol
- must be experiencing a sore throat or cold at least once a year
Key exclusion criteria (15 listed)
- smokers
- liver and kidney disease
- inflammatory bowel disease
- pancreatitis
- gallbladder or biliary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency and duration of colds/sore throats
Time frame: 30 days
Using a self-reported scale to assess the frequency and during of colds and sore throats at screening, and at baseline and endpoint of treatments
1 secondary outcome
Assessment of oral pathogenic bacteria
Time frame: 30 days
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 26 Mar 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?
An observational study of Personal Satisfaction, run by University of Manitoba at 1 site in Canada.
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 15 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 26 Mar 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 Canada. 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.
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?
Frequency and duration of colds/sore throats (time frame: 30 days). 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 26 Mar 2015.