Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease

Last updated: February 18, 2025
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatitis

Pancreatic Disorders

Treatment

Search for exocrine pancreatic insufficiency at week 0 and 12

Clinical Study ID

NCT03915262
69HCL19_0294
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Search for exocrine pancreatic insufficiency at week 0 and 12
Phase:
Study Start date:
November 15, 2019
Estimated Completion Date:
November 15, 2026

Connect with a study center

  • Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL

    Pierre Benite, 69495
    France

    Active - Recruiting

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