Microbial Epidemiology and Chlorhexidine Suscebtibily of Oropharyngeal and Intestinal Colonization (OroColi-HS)

June 9, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Colombes, Ile De France, France, 92700
        • AP-HP, Louis Mourier Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

healthy volonteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
healthy adult subject
oropharyngeal and rectal swabbing to collect Gram-negative bacilli
Other: oropharyngeal swabbing
microbiological sampling will be performed on buccal mucosa with standard swab. only one sample will be done
Other: rectal swabbing
same process as oropharyngeal swabbing will be used to collect rectal microbiological sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of patients with an oropharyngeal gram-negative colonization
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of the a GNB oropharyngeal colonization
Time Frame: Day 1
Day 1
comparision of the predominant fecal flora with GNB oropharyngeal colonization
Time Frame: Day 1
Day 1
characterization of antimicrobial and chlorhexidine susceptibility of Gram negative bacteria from oropharyngeal colonization
Time Frame: Day 1
Day 1
phylogenetic and virulence factor content of E. coli oropharyngeal and rectal colonization
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jonathan MESSIKA, MD, Hopital Louis Mourier - Assistance Publique Hopitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

August 16, 2017

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimated)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • P140907

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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