Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease
Denmark153 participantsStarted 2016-06
Plain-language summary
The purpose of this study is to determine whether Non-invasive endoscopic procedures (pillcam colon capsule endoscopy, PCCE) and non-ionizing radiological modalities (MR enterocolonography, MREC and ultrasound, US) - offer a sufficiently high diagnostic validity in patients with suspected CD compared to the traditional invasive approach using ileocolonoscopy with biopsies as first line diagnostic modality
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
General criterion
All of the following:
* Clinical suspicion of CD
* Age \> 15 years
* Negative serologic markers for celiac disease, negative stool culture (or polymerase chain reaction) for pathogenic bacteria and a negative microscopy for intestinal parasites
* Fecal calprotectin \> 50 mg/kg
* Signed informed consent
Clinical criterion Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) associated with one or more of the following findings: (1) C-reactive protein (CRP) \>5 mg/L, (2) 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), (3) prolonged fever (\> 37.5 C for more than 2 weeks), (5) weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight), (6) perianal abscess/fistula, or (7) a family history of inflammatory bowel disease.
Exclusion Criteria:
* Acute bowel obstruction
* Intake of NSAIDs or acetylsalicylic acid ≤ 4 weeks before inclusion except prophylactic treatment with low dose Aspirin (≤ 150 mg per day)
* Pregnancy or lactation
* Alcohol or drug abuse
* Known gastrointestinal disorder other than inflammatory bowel disease
* Renal failure defined by a plasma-creatinine above the normal reference range
* Claustrophobia, cardiac pacemaker or implanted magnetic foreign bodies that precludes MREC
* Interpreter required or inability to understand the oral and written inf…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity and specificity of PCCE, MREC and US for the diagnosis of CD
Timeframe: 36 months
2
Correlation of disease severity
Timeframe: 36 months
3
Inter-observer agreement
Timeframe: 36 months
Trial details
NCT IDNCT03134586
SponsorEsbjerg Hospital - University Hospital of Southern Denmark