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

Recruiting now

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT03915262

Run by

Hospices Civils de Lyon

People needed

50

Starts

2019-11-15

Expected to finish

2027-11-15

Last updated by the study team

2026-01-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL — Pierre-Bénite, France (enrolling)

Full record on ClinicalTrials.gov

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