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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Clinical suspicion of CD\* - Age 18-40 years - Signed willing to sign a consent form \*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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

Panenteric capsule endoscopy

Panenteric capsule endoscopy

DIAGNOSTIC_TEST

Ileocolonoscopy

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

DIAGNOSTIC_TEST

MRI enterography

MRI of the small bowel

DIAGNOSTIC_TEST

Small 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
Malmo, Sweden