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Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

Comparative Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization of Healthy Adults Subjects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02840656
Acronym
OroColi-HS
Enrollment
100
Registered
2016-07-21
Start date
2016-09-30
Completion date
2020-11-30
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Gram-negative Bacilli Colonization

Brief summary

In this prospective observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in healthy subjects, and their susceptibility to chlorehexidine. We plan to recruit 100 healthy volunteers secondary endpoints are to determine the phylogentic characteristics of E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal of predominant GNB colonization.

Detailed description

In this prospective observational study we aim to determine the prevalence of oropharyngeal and rectal Gram-negative bacilli colonization in 100 healthy subjects, and their susceptibility to chlorehexidine. Each participant will undego a oropharyngeal swab collection and a rectal swab at day 0. The Gram-negative bacilli colonization will be identified, E. coli isolates will be studied in terms of phylogeny; gram-negative isolates will be studied in terms of antimicrobial and chlorhexidine susceptibility. The primary objective is to determine the prevalence of oropharyngeal Gram-negative bacilli colonization. The secondary objectives are to determine the chlorhexidine and antimicrobial susceptibility of such colonization; to determine the phylogentic characteristics of oropharyngeal and rectal predominant E. coli isolates; to compare the phylogentic characteristics of oropharyngeal and rectal E. coli isolates.

Interventions

OTHERoropharyngeal swabbing

microbiological sampling will be performed on buccal mucosa with standard swab. only one sample will be done

OTHERrectal swabbing

same process as oropharyngeal swabbing will be used to collect rectal microbiological sample

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* age \> 18 yo * personal history of neck or face irradiation * no history of gastrointestinal disease * no symptoms of immunosuppression * no antibiotic therapy in the previous month * no hospitalization in the 3 months preceding inclusion * medical exmination prior to inclusion

Exclusion criteria

* affiliated to the social security * The refusal of a patient to participate in a study

Design outcomes

Primary

MeasureTime frame
proportion of patients with an oropharyngeal gram-negative colonizationDay 1

Secondary

MeasureTime frame
incidence of the a GNB oropharyngeal colonizationDay 1
comparision of the predominant fecal flora with GNB oropharyngeal colonizationDay 1
characterization of antimicrobial and chlorhexidine susceptibility of Gram negative bacteria from oropharyngeal colonizationDay 1
phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonizationDay 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026