GastroenteritisPREPHAGENCT06524791
Prevalence of Faecal Bacteriophage in Patients With Digestive Symptoms
An observational study of Gastroenteritis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastroenteritis
- What is being tested?
- bacteriophage detection
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2024to 15 Nov 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: patients hospitalized at the CHRU de Nancy with digestive symptoms requiring microbiological stool analysis
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
- Conditions
- Gastroenteritis
- Being tested
- bacteriophage detection
- Keywords
- bacteriophages
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bacteriophage detectionOther
bacteriophage detection
| Study group | Role | What they receive |
|---|---|---|
| immunocompetent | immunocompetent patients with digestive symptoms (n=150) Receives: Other: bacteriophage detection | |
| immunocompromised | immunocompromised patients with digestive symptoms (n=150) Receives: Other: bacteriophage detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of faecal phage carriage
define the prevalence of faecal phage (coliphage) carriage in individuals presenting with digestive symptoms.
Measured: baseline
Secondary outcomes (2)
concentrations of infectious fecal phages
Determine the concentrations of infectious fecal phages in the stools of individuals with digestive symptoms (detection by culture)
Measured: baseline
fecal phage genome concentrations
determine fecal phage genome concentrations in the stools of individuals with digestive symptoms (PCR detection)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HARTARD Cédric, Central Hospital, Nancy, France
- Investigators
- Cédric Hartard, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524791
- Sponsor's protocol ID
- 2023-0323
- Acronym
- PREPHAGE
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Faecal Bacteriophage Carriage in Patients With Digestive Symptoms.
- ClinicalTrials.gov ID
- NCT06524791
- Acronym / sponsor ID
- PREPHAGE / 2023-0323
- Conditions
- Gastroenteritis
- Keywords
- bacteriophages
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immunocompetent | – | Other: bacteriophage detectionimmunocompetent patients with digestive symptoms (n=150) |
| immunocompromised | – | Other: bacteriophage detectionimmunocompromised patients with digestive symptoms (n=150) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- patients hospitalized at the CHRU de Nancy with digestive symptoms requiring microbiological stool analysis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bacteriophage detectionbacteriophage detection | Other | immunocompetent, immunocompromised |
Primary outcome
prevalence of faecal phage carriage
Time frame: baseline
define the prevalence of faecal phage (coliphage) carriage in individuals presenting with digestive symptoms.
2 secondary outcomes
concentrations of infectious fecal phages
Time frame: baseline
fecal phage genome concentrations
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
Related trials for Gastroenteritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric Hartard principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteritis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cédric Hartard (0383153046, c.hartard@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of faecal phage carriage (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.