Common ColdNCT02535442
Nasal Swab Study to Explore the Nasal Microbia
An observational study of Common Cold, run by Kimberly-Clark Corporation at 1 site in United States.
Trial summary
The objective of this study is to evaluate the microbial consortia and the host inflammatory factors present in the nasal passages of patients during upper respiratory symptomology and when healthy using culture and molecular analysis techniques. 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
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Jun 2016
- 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: Community sample of male and female subjects with common cold symptoms.
Who may be able to join
- Adults, male or female, between the ages 18 - 60
- Exhibiting symptoms of an upper respiratory ailment, which may include runny or stuffy nose, sore throat, fever, headache, cough, malaise, or loss of appetite with no indication or intention to treat with excluded medications.
Who cannot join
- Use of antibiotics, antifungals, antivirals, antihistamines, anticholinergic, anti-inflammatory, any nasal inhaled medications (other than saline), or steroid medications within the four (4) weeks prior to enrollment and during the course of the study. Use of cough suppressants and herbal medications are permitted.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
About this study
Official title: An Exploratory Study to Evaluate the Microbial Consortia and the Host Inflammatory Factors Present in the Nasal Passages of Patients During Upper Respiratory Symptomology and When Healthy
The objective of this study is to evaluate the microbial consortia and the host inflammatory factors present in the nasal passages of patients during upper respiratory symptomology and when healthy using culture and molecular analysis techniques.
- Conditions
- Common Cold
- Medical subject headings
- Common Cold
What is being measured
The primary outcome is the main question the study is designed to answer.
Type and amount of nasal microbes
Measured: Change from baseline compared to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Common ColdStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly-Clark Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Fogarty, MD, Principal investigator, Spartanburg Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535442
- Sponsor's protocol ID
- 500-15-0003
- Status last verified
- Jul 2016
- First submitted
- 14 Aug 2015
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolcott RD, Dowd SE. A rapid molecular method for characterising bacterial bioburden in chronic wounds. J Wound Care. 2008 Dec;17(12):513-6. doi: 10.12968/jowc.2008.17.12.31769.
PubMed 19052515Dowd SE, Wolcott RD, Sun Y, McKeehan T, Smith E, Rhoads D. Polymicrobial nature of chronic diabetic foot ulcer biofilm infections determined using bacterial tag encoded FLX amplicon pyrosequencing (bTEFAP). PLoS One. 2008 Oct 3;3(10):e3326. doi: 10.1371/journal.pone.0003326.
PubMed 18833331Callaway TR, Dowd SE, Wolcott RD, Sun Y, McReynolds JL, Edrington TS, Byrd JA, Anderson RC, Krueger N, Nisbet DJ. Evaluation of the bacterial diversity in cecal contents of laying hens fed various molting diets by using bacterial tag-encoded FLX amplicon pyrosequencing. Poult Sci. 2009 Feb;88(2):298-302. doi: 10.3382/ps.2008-00222.
PubMed 19151343Wolcott RD, Gontcharova V, Sun Y, Dowd SE. Evaluation of the bacterial diversity among and within individual venous leg ulcers using bacterial tag-encoded FLX and titanium amplicon pyrosequencing and metagenomic approaches. BMC Microbiol. 2009 Oct 27;9:226. doi: 10.1186/1471-2180-9-226.
PubMed 19860898Dowd SE, Callaway TR, Wolcott RD, Sun Y, McKeehan T, Hagevoort RG, Edrington TS. Evaluation of the bacterial diversity in the feces of cattle using 16S rDNA bacterial tag-encoded FLX amplicon pyrosequencing (bTEFAP). BMC Microbiol. 2008 Jul 24;8:125. doi: 10.1186/1471-2180-8-125.
PubMed 18652685
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Microbial Consortia and the Host Inflammatory Factors Present in the Nasal Passages of Patients During Upper Respiratory Symptomology and When Healthy
- ClinicalTrials.gov ID
- NCT02535442
- Acronym / sponsor ID
- 500-15-0003
- Conditions
- Common Cold
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Kimberly-Clark CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Aug 2015 (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 objective of this study is to evaluate the microbial consortia and the host inflammatory factors present in the nasal passages of patients during upper respiratory symptomology and when healthy using culture and molecular analysis techniques.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample of male and female subjects with common cold symptoms.
Key inclusion criteria (2 listed)
- Adults, male or female, between the ages 18 - 60
- Exhibiting symptoms of an upper respiratory ailment, which may include runny or stuffy nose, sore throat, fever, headache, cough, malaise, or loss of appetite with no indication or intention to treat with excluded medications.
Key exclusion criteria (1 listed)
- Use of antibiotics, antifungals, antivirals, antihistamines, anticholinergic, anti-inflammatory, any nasal inhaled medications (other than saline), or steroid medications within the four (4) weeks prior to enrollment and during the course of the study. Use of cough suppressants and herbal medications are permitted.
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
Type and amount of nasal microbes
Time frame: Change from baseline compared to Day 21
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 4 Jul 2016.
- Background: PubMed 19052515Wolcott RD, Dowd SE. A rapid molecular method for characterising bacterial bioburden in chronic wounds. J Wound Care. 2008 Dec;17(12):513-6. doi: 10.12968/jowc.2008.17.12.31769.
- Background: PubMed 18833331Dowd SE, Wolcott RD, Sun Y, McKeehan T, Smith E, Rhoads D. Polymicrobial nature of chronic diabetic foot ulcer biofilm infections determined using bacterial tag encoded FLX amplicon pyrosequencing (bTEFAP). PLoS One. 2008 Oct 3;3(10):e3326. doi: 10.1371/journal.pone.0003326.
- Background: PubMed 19151343Callaway TR, Dowd SE, Wolcott RD, Sun Y, McReynolds JL, Edrington TS, Byrd JA, Anderson RC, Krueger N, Nisbet DJ. Evaluation of the bacterial diversity in cecal contents of laying hens fed various molting diets by using bacterial tag-encoded FLX amplicon pyrosequencing. Poult Sci. 2009 Feb;88(2):298-302. doi: 10.3382/ps.2008-00222.
- Background: PubMed 19860898Wolcott RD, Gontcharova V, Sun Y, Dowd SE. Evaluation of the bacterial diversity among and within individual venous leg ulcers using bacterial tag-encoded FLX and titanium amplicon pyrosequencing and metagenomic approaches. BMC Microbiol. 2009 Oct 27;9:226. doi: 10.1186/1471-2180-9-226.
- Background: PubMed 18652685Dowd SE, Callaway TR, Wolcott RD, Sun Y, McKeehan T, Hagevoort RG, Edrington TS. Evaluation of the bacterial diversity in the feces of cattle using 16S rDNA bacterial tag-encoded FLX amplicon pyrosequencing (bTEFAP). BMC Microbiol. 2008 Jul 24;8:125. doi: 10.1186/1471-2180-8-125.
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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.
Charles Fogarty, MD principal investigator
Spartanburg Medical Research
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 Common Cold, run by Kimberly-Clark Corporation 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 2 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: finished, as of the sponsor's last update on 4 Jul 2016. 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.
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?
Type and amount of nasal microbes (time frame: Change from baseline compared to Day 21). 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 NCT02535442, which also lists 5 linked publications.
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 4 Jul 2016.