Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease (IPEC)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Crohn Disease

Treatments: Biological: Search for exocrine pancreatic insufficiency at week 0 and 12

Study type: Observational

Funder types: Other

Identifiers

NCT03915262

69HCL19_0294

Details and patient eligibility

About

This study aims to assess the prevalence of exocrine pancreatic insufficiency (EPI) in a population of patients with active Crohn's disease. Studies already describe a prevalence rate around 18-66%. In this multicentric prospective study, we plan to compare EPI's prevalence at week 0 and week 14 of an induction phase of a biological therapy. The biological therapy will be initiate for an active Crohn's disease. Secondary outcomes will be: malnutrition's prevalence, and Crohn's disease activity level.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age of 18 years or more
• Crohn's disease diagnosed for more than 3 months.
• Active Crohn's disease : CDAI score > 150 + [CRP > 5 mg/L or faecal calprotectin > 250mcg/g or endoscopic lesion or MRI lesion]
• Indication of a biological therapy (anti-TNFα, vedolizumab ou ustekinumab).

Exclusion criteria

• Crohn's disease that doesn't fit the previous criteria
• Extended resection of small intestine (>40cm)
• Chronic pancreatitis diagnosed before inclusion
• Contraindication to biological therapy (anti-TNFα, vedolizumab ou ustekinumab)
• Pancreatic enzyme replacement therapy
• Pregnant or breastfeeding woman
• Patient under the protection of a conservator

Trial design

50 participants in 1 patient group

Crohn's Disease

Treatment:

Biological: Search for exocrine pancreatic insufficiency at week 0 and 12