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

NCT03915262 | Recruiting

• 1 other identifier: 69HCL19_0294
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (2)

• Exocrine pancreatic insufficiency's prevalence

  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%

  week 0

• Exocrine pancreatic insufficiency's prevalence

  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%

  week 14

Study Arms (1)

Crohn's Disease

Biological: Search for exocrine pancreatic insufficiency at week 0 and 12

Interventions

Search for exocrine pancreatic insufficiency at week 0 and 12 BIOLOGICAL

We will collect 24 hours stool to search for steatorrhea, and to measure elastase and calprotectin. We will collect a total of 8 additional blood tubes (25mL), during regular blood sampling for a patient under biological therapy for a Crohn's disease. We will gather the total caloric and fat intake with a diet record.

Crohn's Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an active Crohn's Disease

You may qualify if:

• 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).

You may not qualify if:

• 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
• Pregnant or breastfeeding woman
• Patient under the protection of a conservator

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Pierre-Bénite, 69495, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Gilles BOSCHETTI

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles BOSCHETTI, MD

CONTACT

478860302; gilles.boschetti@chu-lyon.fr

Charlotte BERGOIN, MD

CONTACT

478863869; charlotte.bergoin@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 16, 2019
• Study Start: November 15, 2019
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

FR (1)