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

Recruiting

• Conditions: Crohn Disease
• Interventions: Biological: Search for exocrine pancreatic insufficiency at week 0 and 12

• Registration Number: NCT03915262
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-16
• Study Start: 2019-11-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-02
• Last Update Posted: 2023-01-04
• Primary Completion: 2024-11-15
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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).

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Crohn's Disease	Search for exocrine pancreatic insufficiency at week 0 and 12	-

Primary Outcome Measures

Name	Time	Method
Exocrine pancreatic insufficiency's prevalence	week 14	Exocrine pancreatic insufficiency will be defined as the association of : fecal elastase \<200 mcg/g and steatorrhea (\>7g of fecal fat per day) or an fat absorption rate \< 95%

Trial Locations

Locations (1)

Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL; 🇫🇷 Pierre Benite, France