Prevalence of Faecal Bacteriophage in Patients With Digestive Symptoms

NCT06524791 | Not Yet Recruiting

• 1 other identifier: 2023-0323
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Gastroenteritis

Keywords

bacteriophages

Outcome Measures

Primary Outcomes (1)

• prevalence of faecal phage carriage

  define the prevalence of faecal phage (coliphage) carriage in individuals presenting with digestive symptoms.

  baseline

Secondary Outcomes (2)

• concentrations of infectious fecal phages

  baseline

• fecal phage genome concentrations

  baseline

Study Arms (2)

immunocompetent

immunocompetent patients with digestive symptoms (n=150)

Other: bacteriophage detection

immunocompromised

immunocompromised patients with digestive symptoms (n=150)

Other: bacteriophage detection

Interventions

bacteriophage detection OTHER

bacteriophage detection

immunocompetent; immunocompromised

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, 54000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

stool sample

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Cédric Hartard

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cédric Hartard

CONTACT

0383153046; c.hartard@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: November 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

FR (1)