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NCT Number: NCT02840656

Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization

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.

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Key information

Conditions

Oropharyngeal Gram-negative Bacilli Colonization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Louis Mourier Hospital

Colombes, Île-de-France Region, 92700, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oropharyngeal swabbing

Other

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

rectal swabbing

Other

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

Primary outcomes

  1. proportion of patients with an oropharyngeal gram-negative colonization

    Time frame: Day 1

Secondary outcomes

  1. incidence of the a GNB oropharyngeal colonization

    Time frame: Day 1

  2. comparision of the predominant fecal flora with GNB oropharyngeal colonization

    Time frame: Day 1

  3. characterization of antimicrobial and chlorhexidine susceptibility of Gram negative bacteria from oropharyngeal colonization

    Time frame: Day 1

  4. phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: OroColi-HS

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Jul 21, 2016
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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