Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease
Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy
Hospices Civils de Lyon
50 participants
Nov 15, 2019
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria7
- 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
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT03915262