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

Crohn Disease Clinical Trial

— IPEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03915262
• Other study ID #: 69HCL19_0294
• Status: Recruiting
• Start date: November 15, 2019
• Est. completion date: November 15, 2024

Study information

• Verified date: January 2023
• Source: Hospices Civils de Lyon
• Contact: Gilles BOSCHETTI, MD
• Phone: 478860302
• Email: gilles.boschetti[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-TNFa, 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-TNFa, vedolizumab ou ustekinumab)

• Pancreatic enzyme replacement therapy

• Pregnant or breastfeeding woman

• Patient under the protection of a conservator

Related Conditions & MeSH terms

• Crohn Disease
• Exocrine Pancreatic Insufficiency

Intervention

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.

Locations

Country	Name	City	State
France	Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL	Pierre Benite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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