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

Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03915262

Acronym

IPEC

Enrollment

Registered

2019-04-16

Start date

2019-11-15

Completion date

2027-11-15

Last updated

2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

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.

Interventions

BIOLOGICALSearch for exocrine pancreatic insufficiency at week 0 and 12

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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Exocrine pancreatic insufficiency's prevalence	week 0	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%

Countries

France

Contacts

Primary ContactGilles BOSCHETTI, MD

gilles.boschetti@chu-lyon.fr478860302

Backup ContactCharlotte BERGOIN, MD

charlotte.bergoin@chu-lyon.fr478863869

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026