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

NCT06882993 · tracked via the Priya Life Science Denmark tracker

Sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Phase

Not applicable

Started

2025-02-26

Last updated

2026-09-09

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

Panenteric capsule endoscopyIleocolonoscopyMRI enterographySmall bowel capsule endoscopy

Panenteric capsule endoscopy: Panenteric capsule endoscopy

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

MRI enterography: MRI of the small bowel

Small bowel capsule endoscopy: Capsule endoscopy of the small bowel

Study 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

Sex

ALL

Min age

18 Years

Max age

40 Years

Healthy volunteers

Inclusion Criteria: * Clinical suspicion of CD\* * Age 18-40 years * Signed informed consent \*A clinical suspicion of CD is based on the following definition: * Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) and either * fecal calprotectin ≥ 200 mg/kg or * fecal calprotectin ≥ 50 mg/kg plus one or more of the following findings: * C-reactive protein (CRP) \> 5 mg/L * Thrombocytosis (\> 400 x 109/L) * Anemia (hemoglobin \< 7.0 mmol/L for women and \< 8.0 mmol/L for men or a decrease \> 0.5 mmol/L compared to the usual level) * Prolonged fever (\> 37.5 ◦C for more than 2 weeks) * Weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight) * Perianal abscess / fistula * Family history of inflammatory bowel disease. Exclusion Criteria: * 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 * Suspected or established acute bowel obstruction (ileus) * Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion, except low-dose, prophylactic acetylsalicylic acid (≤ 150 mg per day) * Intake of opioid or opioid-like medications ≤ 1 week before inclusion * Pregnancy or lactation * Inability to comply with protocol requirements, e.g. for reasons including alcohol or recreational drug abuse * Known gastrointestinal disorder other than functional gastrointestinal disorders * Renal failure defined by a plasma-creatinine above the normal reference range

Primary outcome measure(s)

Diagnostic completeness — Immediately after initial diagnostic procedure
Proportion of patients in each arm achieving a complete gastrointestinal assessment and an unambiguous diagnosis after completion of the initial diagnostic procedure(s) without need for supplementary examinations

Trial sites (5)

Facility	City	Region	Status
Esbjerg Hospital - University Hospital of Southern Denmark	Esbjerg	Denmark	Recruiting
Odense University Hospital	Odense C	Denmark	Recruiting
Odense University Hospital - Svendborg Hospital	Svendborg	Denmark	Recruiting
Lillebaelt Hospital Vejle - University Hospital of Southern Denmark	Vejle	Denmark	Recruiting
Skåne University Hospital	Malmö	Sweden	Recruiting

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Other trials for the same condition

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease Recruiting

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008) Recruiting

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease Recruiting

Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight Recruiting

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06882993 on ClinicalTrials.gov ↗ ← All trials in Denmark