Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease
Recruiting · NCT03915262 · Observational (researchers observe without assigning treatment) · Lead sponsor: Hospices Civils de Lyon
View the official record on ClinicalTrials.gov →Interventions studied
Search for exocrine pancreatic insufficiency at week 0 and 12
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL - Pierre-Bénite, France