Prevalence of Faecal Bacteriophage in Patients With Digestive Symptoms

NCT ID: NCT06524791

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-11-15

Brief Summary

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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)

Detailed Description

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Conditions

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Gastroenteritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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immunocompetent

immunocompetent patients with digestive symptoms (n=150)

bacteriophage detection

Intervention Type OTHER

bacteriophage detection

immunocompromised

immunocompromised patients with digestive symptoms (n=150)

bacteriophage detection

Intervention Type OTHER

bacteriophage detection

Interventions

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bacteriophage detection

bacteriophage detection

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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HARTARD Cédric

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cédric Hartard

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Locations

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CHRU Nancy

Nancy, , France

Site Status

Countries

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France

Central Contacts

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Cédric Hartard

Role: CONTACT

0383153046

Other Identifiers

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2023-0323

Identifier Type: -

Identifier Source: org_study_id

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