NCT03915262Recruiting
Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease
Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy
Source: ClinicalTrials.gov · Last updated 2 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 9 Apr 2019
- Start date
- 15 Nov 2019
- Primary completion date
- 15 Nov 2026
- Lead sponsor
- Hospices Civils de Lyon
- Diseases
- Crohn's disease
- NCT number
- NCT03915262
What you commit to
- Study type: Observational
- Planned participants: 50
- From 15 Nov 2019 to the primary completion date, 15 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Crohn's disease that doesn't fit the previous criteria
- Extended resection of small intestine (\>40cm)
- Contraindication to biological therapy (anti-TNFα, vedolizumab ou ustekinumab)
- Pancreatic enzyme replacement therapy
Other
- Chronic pancreatitis diagnosed before inclusion
- Pregnant or breastfeeding woman
- Patient under the protection of a conservator
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.