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Not yet recruitingNCT06524791PREPHAGEUpdated Jul 30, 2024

Prevalence of Faecal Bacteriophage in Patients With Digestive Symptoms

An observational study in Gastroenteritis, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by Central Hospital, Nancy, France · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 60 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Gastroenteritis

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Keywords

  • bacteriophages
03

In context

Gastroenteritis

237 studies on the registry are indexed under Gastroenteritis; 16 are open to participants now.

This study's planned enrollment of 300 is below the median of 606 across 62 observational studies indexed under Gastroenteritis.

Browse Gastroenteritis studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • immunocompetent

    immunocompetent patients with digestive symptoms (n=150)

    Other: bacteriophage detection

  • immunocompromised

    immunocompromised patients with digestive symptoms (n=150)

    Other: bacteriophage detection

Interventions

  • Otherbacteriophage detection

    bacteriophage detection

06

What researchers measure

Primary outcomes

  1. prevalence of faecal phage carriage

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

    Time frame: baseline

Secondary outcomes

  1. concentrations of infectious fecal phages

    Determine the concentrations of infectious fecal phages in the stools of individuals with digestive symptoms (detection by culture)

    Time frame: baseline

  2. fecal phage genome concentrations

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

    Time frame: baseline

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2024; primary completion for Nov 2024, 0 months later.

Of 17 observational studies under Gastroenteritis, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 161. This study's planned 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2024
First posted
Jul 29, 2024
StartEst.
Nov 15, 2024
Primary completionEst.
Nov 15, 2024
CompletionEst.
Nov 15, 2025
Last update
Jul 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06524791
Lead sponsor
Central Hospital, Nancy, France
Responsible party
HARTARD Cédric (Principal Investigator, Central Hospital, Nancy, France) — Principal investigator
First posted
Jul 29, 2024
Start date
Nov 15, 2024 (estimated)
Primary completion
Nov 15, 2024 (estimated)
Completion
Nov 15, 2025 (estimated)
Last update
Jul 30, 2024

Study contacts

Cédric Hartard
Contact
c.hartard@chru-nancy.fr
0383153046
Cédric Hartard
principal investigator · CHRU Nancy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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