Checks for pancreas problems in people with active Crohn's disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with active Crohn's disease who are about to start a biological therapy. It checks how often the pancreas does not make enough digestive enzymes.

Age

18 years or older

Sex

All sexes can join

Disease stage

Crohn's disease diagnosed for more than 3 months and active: CDAI score above 150, plus raised CRP (above 5 mg/L) or faecal calprotectin (above 250mcg/g), or a lesion seen on endoscopy or MRI.

Earlier treatment

A biological therapy (anti-TNFα, vedolizumab or ustekinumab) must be planned. People already on pancreatic enzyme replacement therapy cannot join.

Main reasons for not taking part

• Removal of more than 40cm (16 in) of small intestine
• Chronic pancreatitis diagnosed before joining
• Cannot take anti-TNFα, vedolizumab or ustekinumab
• Pancreatic enzyme replacement therapy
• Pregnant or breastfeeding women

The registry criteria, word for word

What the trial wants to find out

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.

The group in the trial

• Crohn's Disease

  Treatment: Search for exocrine pancreatic insufficiency at week 0 and 12