Clinical trial NCT02535442: Nasal Swab Study to Explore the Nasal Microbia
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Common Cold
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
First posted: 2015-08-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample of male and female subjects with common cold symptoms.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Type and amount of nasal microbes
timeFrame: Change from baseline compared to Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
Study officials:
affiliation: Spartanburg Medical Research
name: Charles Fogarty, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Dowd 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.
citation: Callaway 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.
citation: Wolcott 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.
citation: Dowd 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.