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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

NCT ID NCT06882993

NEW Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 165 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Esbjerg Hospital - University Hospital of Southern Denmark

    RECRUITING

    Esbjerg, 6700, Denmark

  • Lillebaelt Hospital Vejle - University Hospital of Southern Denmark

    RECRUITING

    Vejle, 7100, Denmark

  • Odense University Hospital

    RECRUITING

    Odense C, 5000, Denmark

  • Odense University Hospital - Svendborg Hospital

    RECRUITING

    Svendborg, 5700, Denmark

  • Skåne University Hospital

    RECRUITING

    Malmö, 205 02, Sweden

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