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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospices Civils de Lyon
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation Hospices Civils de Lyon
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries France

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Arms & Interventions


: 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Pierre Benite, France




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

Pierre Benite, , 69495

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