Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Search for exocrine pancreatic insufficiency at week 0 and 12.
- Who it may be relevant to
- Registry conditions: Crohn Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy
Overview
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.
Interventions
- 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.
Primary outcome measures
- Exocrine pancreatic insufficiency's prevalence [Time frame: week 0]
- Exocrine pancreatic insufficiency's prevalence [Time frame: week 14]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL — Pierre-Bénite
Identifiers
NCT: NCT03915262 · 69HCL19_0294