BridgeMD
New treatment option for Crohn's Disease
Official title Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
ClinicalTrials.gov ID: NCT06882993
What this study is testing
- What it's testing
- 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?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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 \ 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Esbjerg, Denmark
- Odense C, Denmark
- Svendborg, Denmark
- Vejle, Denmark
- Malmö, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Esbjerg, Denmark; Odense C, Denmark; Svendborg, Denmark; Vejle, Denmark; Malmö, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.