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Status unknownNCT05759104Updated Mar 8, 2023

Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population

An observational study in Crohn Disease, sponsored by Central Hospital, Nancy, France. Status unknown. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
40
Ages
3 Years to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Crohn Disease

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Keywords

  • fistula
  • abscess
  • pediatrics
  • medical treatment
  • surgery
  • drug
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 40 is below the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

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

04

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • Minor patients (aged 3 to 18).
  • Diagnosed with Crohn's disease.
  • fistulizing crohn's disease

Exclusion criteria

Exclusion Criteria:

  • perianal crohn disease
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
40 participants (actual)
Patient registry
No

Interventions

  • DrugInfliximab

    Drug

    Also known as: Adalimumab, Ustékinumab

  • ProcedureStomy

    Surgery

    Also known as: Resection

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 12 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05759104
Lead sponsor
Central Hospital, Nancy, France
Responsible party
CHABOT Caroline (Doctor, Central Hospital, Nancy, France) — Principal investigator
First posted
Mar 8, 2023
Start date
Jan 1, 2012
Primary completion
Jul 1, 2013
Completion
Jul 1, 2023 (estimated)
Last update
Mar 8, 2023

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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