RecruitingNot ApplicableNCT06882993

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

Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease - a Prospective Comparison of Pan-Enteric Capsule Endoscopy Versus Ileocolonoscopy Plus MR Enterography or Small-Bowel Capsule Endoscopy


Sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Enrollment

165 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a less invasive way to diagnose Crohn's disease — an inflammatory bowel condition — in young adults. Instead of going straight to colonoscopy, the approach uses stool tests, blood tests, and imaging to confirm the diagnosis with fewer procedures. **You may be eligible if...** - You are between 18 and 40 years old - You have had ongoing or recurring diarrhea and/or abdominal pain for more than a month, along with certain elevated stool or blood markers suggesting bowel inflammation **You may NOT be eligible if...** - You have previously had intestinal surgery - You have celiac disease or a detectable intestinal infection (bacteria or parasites) - You have a suspected bowel obstruction - You recently took NSAIDs or opioid-like pain medications - You are pregnant or breastfeeding - You have a known gastrointestinal disease other than a functional one - You have kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPanenteric capsule endoscopy

Panenteric capsule endoscopy

DIAGNOSTIC_TESTIleocolonoscopy

Endoscopic examination of the colon and terminal ileum after bowel preparation.

DIAGNOSTIC_TESTMRI enterography

MRI of the small bowel

DIAGNOSTIC_TESTSmall bowel capsule endoscopy

Capsule endoscopy of the small bowel


Locations(5)

Esbjerg Hospital - University Hospital of Southern Denmark

Esbjerg, Denmark

Odense University Hospital

Odense C, Denmark

Odense University Hospital - Svendborg Hospital

Svendborg, Denmark

Lillebaelt Hospital Vejle - University Hospital of Southern Denmark

Vejle, Denmark

Skåne University Hospital

Malmö, Sweden

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NCT06882993


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