Crohn DiseaseNCT05759104
Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population
An observational study of Crohn Disease, run by Central Hospital, Nancy, France.
Trial summary
Crohn's disease is a inflammatory bowel disease evolving towards the destruction of the intestinal wall resulting in stenosing or perforating complications (fistulas, abscesses). The treatment of perforating Crohn's disease is not codified. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Infliximab and Stomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 1 Jul 2023
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: * In consultations or hospitalized. * CHRU and CHR of Lille, Strasbourg, Colmar, Besançon, Dijon, Reims and Nancy. * Over the period from January 2012 to January 2022.
Who may be able to join
- Minor patients (aged 3 to 18).
- Diagnosed with Crohn's disease.
- fistulizing crohn's disease
Who cannot join
- perianal crohn disease
About this study
Crohn's disease is a inflammatory bowel disease evolving towards the destruction of the intestinal wall resulting in stenosing or perforating complications (fistulas, abscesses).
The treatment of perforating Crohn's disease is not codified.
Read the detailed description
The old dogmas leading to surgery after failure of medical treatment have recently been overturned, particularly since the advent of anti-TNFs.
Biotherapies now have a central place, including for complicated forms. Previous studies have already looked at the usefulness of anti-TNFs in stenosing forms, or concerning ano-perineal lesions, but what about digestive fistulas.
Indeed, data are scarce, especially in paediatrics.
- Conditions
- Crohn Disease
- Being tested
- Infliximab, Stomy
- Keywords
- fistula, abscess, pediatrics, medical treatment, surgery, drug
- Medical subject headings
- Crohn Disease, Fistula, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called Adalimumab, Ustékinumab
Drug
StomyProcedure or surgery
Also called Resection
Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
No fistula
Complete remission = clinical remission and biological remission and iconographic remission:
- clinical remission (asymptomatic at 12 months from inclusion).
- biological remission (normalization of biological parameters 12 months after inclusion).
- iconographic remission (no active lesion, and in particular no visualized fistula)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Jan 2012
- Primary completion1 Jul 2013
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHABOT Caroline, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759104
- Sponsor's protocol ID
- 2022PI067
- Status last verified
- Feb 2023
- First submitted
- 25 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population
- ClinicalTrials.gov ID
- NCT05759104
- Acronym / sponsor ID
- 2022PI067
- Conditions
- Crohn Disease
- Keywords
- fistula, abscess, pediatrics, medical treatment, surgery, drug
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jul 2013 (actual)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 8 Mar 2023 (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.
Crohn's disease is a inflammatory bowel disease evolving towards the destruction of the intestinal wall resulting in stenosing or perforating complications (fistulas, abscesses).
The treatment of perforating Crohn's disease is not codified.
Detailed description
The old dogmas leading to surgery after failure of medical treatment have recently been overturned, particularly since the advent of anti-TNFs.
Biotherapies now have a central place, including for complicated forms. Previous studies have already looked at the usefulness of anti-TNFs in stenosing forms, or concerning ano-perineal lesions, but what about digestive fistulas.
Indeed, data are scarce, especially in paediatrics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- * In consultations or hospitalized. * CHRU and CHR of Lille, Strasbourg, Colmar, Besançon, Dijon, Reims and Nancy. * Over the period from January 2012 to January 2022.
Key inclusion criteria (3 listed)
- Minor patients (aged 3 to 18).
- Diagnosed with Crohn's disease.
- fistulizing crohn's disease
Key exclusion criteria (1 listed)
- perianal crohn disease
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 |
|---|---|---|
| InfliximabAlso: Adalimumab, UstékinumabDrug | Drug | – |
| StomyAlso: ResectionSurgery | Procedure or surgery | – |
Primary outcome
No fistula
Time frame: 12 month
Complete remission = clinical remission and biological remission and iconographic remission: * clinical remission (asymptomatic at 12 months from inclusion). * biological remission (normalization of biological parameters 12 months after inclusion). * iconographic remission (no active lesion, and in particular no visualized fistula)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Central Hospital, Nancy, 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 1 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 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No fistula (time frame: 12 month). 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 8 Mar 2023.