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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915262
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment
Crohn Disease Biological: Search for exocrine pancreatic insufficiency at week 0 and 12

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : December 2, 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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.





Primary Outcome Measures :
  1. Exocrine pancreatic insufficiency's prevalence [ Time Frame: 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%

  2. Exocrine pancreatic insufficiency's prevalence [ Time Frame: week 14 ]
    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%



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an active Crohn's Disease
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915262


Contacts
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Contact: Gilles BOSCHETTI, MD 478860302 ext +33 gilles.boschetti@chu-lyon.fr
Contact: Charlotte BERGOIN, MD 478863869 ext +33 charlotte.bergoin@chu-lyon.fr

Locations
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France
Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL Recruiting
Pierre Benite, France, 69495
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         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Gilles BOSCHETTI Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03915262    
Other Study ID Numbers: 69HCL19_0294
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Exocrine Pancreatic Insufficiency
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pancreatic Diseases