Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease (IPEC)
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|ClinicalTrials.gov Identifier: NCT03915262|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment|
|Crohn Disease||Biological: Search for exocrine pancreatic insufficiency at week 0 and 12|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
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.
- 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%
- 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%
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
|Contact: Gilles BOSCHETTI, MD||478860302 ext +firstname.lastname@example.org|
|Contact: Charlotte BERGOIN, MD||478863869 ext +email@example.com|
|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|
|Principal Investigator:||Gilles BOSCHETTI||Hospices Civils de Lyon|