Actively Recruiting

Age: 18Years +
All Genders
NCT03915262

Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease

Led by Hospices Civils de Lyon · Updated on 2026-01-02

50

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age of 18 years or more
  • Diagnosed with Crohn's disease for more than 3 months
  • Active Crohn's disease with CDAI score greater than 150 plus elevated CRP (>5 mg/L) or faecal calprotectin (>250 mcg/g) or endoscopic or MRI lesions
  • Indicated for biological therapy including anti-TNFB1, vedolizumab, or ustekinumab
Not Eligible

You will not qualify if you...

  • Crohn's disease not meeting the active disease criteria
  • Extended small intestine resection of more than 40 cm
  • Diagnosis of chronic pancreatitis prior to study
  • Contraindications to biological therapy (anti-TNFB1, vedolizumab, or ustekinumab)
  • Use of pancreatic enzyme replacement therapy
  • Pregnancy or breastfeeding
  • Patient under legal protection by a conservator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL

Pierre-Bénite, France, 69495

Actively Recruiting

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Research Team

G

Gilles BOSCHETTI, MD

CONTACT

C

Charlotte BERGOIN, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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