Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
Not applicable · Testing Panenteric capsule endoscopy, Ileocolonoscopy and MRI enterography · 5 sites · Esbjerg Hospital - University Hospital of Southern Denmark
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Panenteric capsule endoscopy (a diagnostic test), Ileocolonoscopy (a diagnostic test), MRI enterography (a diagnostic test) and Small bowel capsule endoscopy (a diagnostic test) as a way to diagnose or measure disease. Condition(s) listed: Crohn's Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 40
- Any sex
Some of the main requirements, copied from the record:
- Clinical suspicion of CD*
- Age 18-40 years
- Signed informed consent
Plus 11 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 165 participants are expected to take part.
- Start date: 2025-02-26.
- Main results expected around 2027-08-31 (estimate from the record).
- 5 study sites listed (5 marked recruiting) in Denmark and Sweden.
Main thing being measured
- Diagnostic completeness (Immediately after initial diagnostic procedure)
In the researchers’ words
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…
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 | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Disease |
| Lead sponsor | Esbjerg Hospital - University Hospital of Southern Denmark |
| Collaborators | Odense University Hospital; Svendborg Hospital; Skane University Hospital; Vejle Hospital |
| Enrollment | 165 (estimated) |
| Start date | 2025-02-26 |
| Primary completion (est.) | 2027-08-31 |
| First posted | 2025-03-19 |
| Last updated | 2026-09-09 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06882993 |
Interventions
- Panenteric capsule endoscopy (Diagnostic Test)
Panenteric capsule endoscopy - Ileocolonoscopy (Diagnostic Test)
Endoscopic examination of the colon and terminal ileum after bowel preparation. - MRI enterography (Diagnostic Test)
MRI of the small bowel - Small bowel capsule endoscopy (Diagnostic Test)
Capsule endoscopy of the small bowel
Full eligibility criteria (from the record)
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
Locations (5)
| Site | City | Country | Site 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 |
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.