Assessing pancreatic insufficiency in patients with active Crohn's disease
Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy
Hospices Civils de Lyon · NCT03915262
This study looks at how common pancreatic problems are in people with active Crohn's disease before and after starting treatment to see how it affects their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Drugs / interventions | vedolizumab, ustekinumab |
| Locations | 1 site (Pierre-Bénite) |
| Trial ID | NCT03915262 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence of exocrine pancreatic insufficiency (EPI) in patients diagnosed with active Crohn's disease. It will involve a multicentric prospective approach, comparing the prevalence of EPI at the start of biological therapy and again at week 14. The study will also assess secondary outcomes such as malnutrition prevalence and the activity level of Crohn's disease. Participants will be monitored for specific clinical indicators to determine the relationship between Crohn's disease and pancreatic function.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of active Crohn's disease requiring biological therapy.
Not a fit: Patients with chronic pancreatitis, those on pancreatic enzyme replacement therapy, or those with contraindications to biological therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with Crohn's disease by identifying and addressing pancreatic insufficiency.
How similar studies have performed: Previous studies have indicated a significant prevalence of EPI in Crohn's disease, suggesting that this approach is relevant and may yield valuable insights.
Eligibility criteria
Show full 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
Where this trial is running
Pierre-Bénite
- Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL — Pierre-Bénite, France (RECRUITING)
Study contacts
- Principal investigator: Gilles BOSCHETTI — Hospices Civils de Lyon
- Study coordinator: Gilles BOSCHETTI, MD
- Email: gilles.boschetti@chu-lyon.fr
- Phone: 478860302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn Disease