Nasal Swab Study to Explore the Nasal Microbia

NCT02535442 | Completed

• 1 other identifier: 500-15-0003
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• Type and amount of nasal microbes

  Change from baseline compared to Day 21

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample of male and female subjects with common cold symptoms.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kimberly-Clark Corporation: lead

Study Sites (1)

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Related Publications (5)

• 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.

  PMID: 19052515 BACKGROUND

• 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.

  PMID: 18833331 BACKGROUND

• 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.

  PMID: 19151343 BACKGROUND

• 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.

  PMID: 19860898 BACKGROUND

• 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.

  PMID: 18652685 BACKGROUND

Biospecimen

Retention: NONE RETAINED

microbiota from nasal samples

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Charles Fogarty, MD

  Spartanburg Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 28, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 4, 2016

Record last verified: 2016-07

Locations

US (1)