Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorEsbjerg Hospital - University Hospital of Southern Denmark

About this trial

The goal of this clinical trial is to learn whether a camera pill examination of the whole bowel can be used to diagnose Crohn's disease instead of colonoscopy and a small bowel examination (either MRI or camera pill) in patients aged 18-40 years suspected of having Crohn's disease.

The main question it aims to answer is:

How many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations?

Researchers will compare with patients examined with colonoscopy and a small bowel examination.

Participants will:

* Be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination * Have their electronic medical records checked to see if a diagnosis has been made * Have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found

Eligibility criteria

Qualifiers

Clinical suspicion of CD*

Age 18-40 years

Signed informed consent

Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) and either

Disqualifiers

Previous intestinal resection

Positive serologic markers for celiac disease

Positive stool polymerase chain reaction for pathogenic bacteria

Positive stool polymerase chain reaction for intestinal parasites

Trial design

Treatments tested in this trial

  • Panenteric capsule endoscopy
  • Ileocolonoscopy
  • MRI enterography
  • Small bowel capsule endoscopy

Treatment groups

165 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Esbjerg Hospital - University Hospital of Southern Denmark

Lead sponsor

Odense University Hospital

Collaborator

Svendborg Hospital

Collaborator

Skane University Hospital

Collaborator

Vejle Hospital

Collaborator