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NCT Number: NCT03915262

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

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.

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Pierre-Bénite, 69495, France

Location status: Recruiting

Location contact

Bernard FLOURIE, MD, Prof.

SUB_INVESTIGATOR

Charlotte BERGOIN, MD

CONTACT

Charlotte BERGOIN, MD

SUB_INVESTIGATOR

Gilles BOSCHETTI, MD

CONTACT

Gilles BOSCHETTI, MD

PRINCIPAL_INVESTIGATOR

Stéphane NANCEY, MD, Prof.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Search for exocrine pancreatic insufficiency at week 0 and 12

Biological

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 outcomes

  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%

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte BERGOIN, MD

CONTACT

[email protected]

478863869 ext. +33

Gilles BOSCHETTI, MD

CONTACT

[email protected]

478860302 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: IPEC

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Apr 16, 2019
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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