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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05759104
• Other study ID #: 2022PI067
• Status: Active, not recruiting
• Start date: January 1, 2012
• Est. completion date: July 1, 2023

Study information

• Verified date: February 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• perianal crohn disease

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Infliximab
Drug

Procedure:
• Stomy
Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 month