Prevalence of Faecal Bacteriophage in Patients With Digestive Symptoms

Not yet recruiting

• Conditions: Gastroenteritis
• Interventions: Other: bacteriophage detection

• Registration Number: NCT06524791
• Lead Sponsor: Central Hospital, Nancy, France

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-27
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-30
• Study Start: 2024-11-15
• Primary Completion: 2024-11-15
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
immunocompromised	bacteriophage detection	immunocompromised patients with digestive symptoms (n=150)
immunocompetent	bacteriophage detection	immunocompetent patients with digestive symptoms (n=150)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
concentrations of infectious fecal phages	baseline	Determine the concentrations of infectious fecal phages in the stools of individuals with digestive symptoms (detection by culture)
fecal phage genome concentrations	baseline	determine fecal phage genome concentrations in the stools of individuals with digestive symptoms (PCR detection)

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Nancy, France