Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease
Observational · No treatment assigned · 1 site · Hospices Civils de Lyon
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Age of 18 years or more
- Crohn's disease diagnosed for more than 3 months.
- Active Crohn's disease : CDAI score > 150 + \[CRP > 5 mg/L or faecal calprotectin > 250mcg/g or endoscopic lesion or MRI lesion\]
Plus 1 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2019-11-15.
- Main results expected around 2026-11-15 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Exocrine pancreatic insufficiency's prevalence (week 0)
In the researchers’ words
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%.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease |
| Lead sponsor | Hospices Civils de Lyon |
| Enrollment | 50 (estimated) |
| Start date | 2019-11-15 |
| Primary completion (est.) | 2026-11-15 |
| First posted | 2019-04-16 |
| Last updated | 2026-01-02 |
| Official title | Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy |
| ClinicalTrials.gov ID | NCT03915262 |
Interventions
- 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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Service d'Hépato-Gastroentérologie, Centre Hospitalier Lyon-Sud, HCL | Pierre-Bénite | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.