Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease (IPEC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Biological: Search for exocrine pancreatic insufficiency at week 0 and 12

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Gilles BOSCHETTI, MD; Phone Number: +33 478860302; Email: gilles.boschetti@chu-lyon.fr
• Study Contact Backup: Name: Charlotte BERGOIN, MD; Phone Number: +33 478863869; Email: charlotte.bergoin@chu-lyon.fr

Study Locations

• France
  • Pierre Benite, France, 69495
    • Recruiting
    • Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL
    • Contact: Gilles BOSCHETTI, MD
    • Contact: Charlotte BERGOIN, MD
    • Principal Investigator: Gilles BOSCHETTI, MD
    • Sub-Investigator: Stéphane NANCEY, MD, Prof.
    • Sub-Investigator: Bernard FLOURIE, MD, Prof.
    • Sub-Investigator: Charlotte BERGOIN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an active Crohn's Disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Crohn's Disease	Biological: Search 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Gilles BOSCHETTI, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Anticipated): November 15, 2024
• Study Completion (Anticipated): November 15, 2024

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Pancreatic Diseases; Crohn Disease; Exocrine Pancreatic Insufficiency
• Other Study ID Numbers: 69HCL19_0294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No