Assessing pancreatic insufficiency in patients with active Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the prevalence of exocrine pancreatic insufficiency (EPI) in patients diagnosed with active Crohn's disease. It will involve a multicentric prospective approach, comparing the prevalence of EPI at the start of biological therapy and again at week 14. The study will also assess secondary outcomes such as malnutrition prevalence and the activity level of Crohn's disease. Participants will be monitored for specific clinical indicators to determine the relationship between Crohn's disease and pancreatic function.

Why it matters

Who can join: the full rules

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's running

• Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL
  Pierre-Bénite, France Recruiting

Study contacts

• Principal investigator: Gilles BOSCHETTI — Hospices Civils de Lyon
• Study coordinator: Gilles BOSCHETTI, MD
• Email: gilles.boschetti@chu-lyon.fr
• Phone: 478860302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.