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RECRUITINGOBSERVATIONAL

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

Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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). Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

Search for exocrine pancreatic insufficiency at week 0 and 12

We will collect 24 hours stool to search for steatorrhea, and to measure elastase and calprotectin. We will collect a total of 8 additional blood tubes (25mL), during regular blood sampling for a patient under biological therapy for a Crohn's disease. We will gather the total caloric and fat intake with a diet record.

Locations (1)

Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL
Pierre-Bénite, France