Search for exocrine pancreatic insufficiency at week 0 and 12
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.
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Exocrine pancreatic insufficiency's prevalence — week 0 Exocrine pancreatic insufficiency will be defined as the association of : fecal elastase \<200 mcg/g and steatorrhea (\>7g of fecal fat per day) or an fat absorption rate \< 95%
Exocrine pancreatic insufficiency's prevalence — week 14 Exocrine pancreatic insufficiency will be defined as the association of : fecal elastase \<200 mcg/g and steatorrhea (\>7g of fecal fat per day) or an fat absorption rate \< 95%
Trial sites (1)
Facility
City
Region
Status
Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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