Prevalence of Faecal Bacteriophage in Patients With Digestive Symptoms (PREPHAGE)

July 27, 2024 updated by: HARTARD Cédric, Central Hospital, Nancy, France

Evaluation of the Prevalence of Faecal Bacteriophage Carriage in Patients With Digestive Symptoms.

Define the prevalence of fecal phage carriage in individuals with digestive symptoms (i) Determine the concentrations of infectious fecal phages in the stools of individuals with digestive symptoms (detection by culture)

(ii) Determine fecal phage genome concentrations in the stools of individuals with digestive symptoms (PCR detection)

(iii) Explore factors that could impact fecal phage carriage (patients with digestive symptoms vs. healthy individuals, immunocompromised patients vs. immunocompetent patients)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Nancy, France, 54000
        • CHRU Nancy

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

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

patients hospitalized at the CHRU de Nancy with digestive symptoms requiring microbiological stool analysis

Description

Inclusion Criteria:

  • Age between 18 and 60.
  • Persons having developed gastrointestinal symptoms justifying microbiological stool testing at the time of hospitalization.
  • Person having received full information on the organization of the research and not having objected to the use of this data

Exclusion Criteria:

  • Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code.
  • Pregnant or breast-feeding women,
  • Minors (not emancipated),
  • Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice),
  • Persons of full age who are unable to give their consent.
  • Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care by virtue of articles L. 3212-1 and L. 3213-1.

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
immunocompetent
immunocompetent patients with digestive symptoms (n=150)
Other: bacteriophage detection
bacteriophage detection
immunocompromised
immunocompromised patients with digestive symptoms (n=150)
Other: bacteriophage detection
bacteriophage detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of faecal phage carriage
Time Frame: baseline
define the prevalence of faecal phage (coliphage) carriage in individuals presenting with digestive symptoms.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
concentrations of infectious fecal phages
Time Frame: baseline
Determine the concentrations of infectious fecal phages in the stools of individuals with digestive symptoms (detection by culture)
baseline
fecal phage genome concentrations
Time Frame: baseline
determine fecal phage genome concentrations in the stools of individuals with digestive symptoms (PCR detection)
baseline

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Cédric Hartard, CHRU Nancy

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 (Estimated)

November 15, 2024

Primary Completion (Estimated)

November 15, 2024

Study Completion (Estimated)

November 15, 2025

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 29, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2024

Last Update Submitted That Met QC Criteria

July 27, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0323

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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