Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
ANDI-3
1 other identifier
interventional
165
2 countries
5
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2025
CompletedStudy Start
First participant enrolled
February 26, 2025
CompletedFirst Posted
Study publicly available on registry
March 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
March 19, 2025
March 1, 2025
2.5 years
February 26, 2025
March 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic completeness
Proportion of patients in each arm achieving a complete gastrointestinal assessment and an unambiguous diagnosis after completion of the initial diagnostic procedure(s) without need for supplementary examinations
Immediately after initial diagnostic procedure
Secondary Outcomes (8)
Feasibility of pan-enteric CE
After completion of follow-up (12 months)
Additional examinations
After completion of follow-up (12 months)
Safety
After completion of follow-up (12 months)
Time to diagnosis
After completion of follow-up (12 months)
Disease classification and medical treatments
After completion of follow-up (12 months)
- +3 more secondary outcomes
Study Arms (2)
Minimally invasive diagnostic algorithm
EXPERIMENTALTraditional work-up
ACTIVE COMPARATORColonoscopy and either MRI enterography or small bowel capsule endoscopy
Interventions
Panenteric capsule endoscopy
Endoscopic examination of the colon and terminal ileum after bowel preparation.
Eligibility Criteria
You may qualify 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
- 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.
You may not qualify 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Esbjerg Hospital - University Hospital of Southern Denmarklead
- Odense University Hospitalcollaborator
- Svendborg Hospitalcollaborator
- Skane University Hospitalcollaborator
- Vejle Hospitalcollaborator
Study Sites (5)
Esbjerg Hospital - University Hospital of Southern Denmark
Esbjerg, 6700, Denmark
Odense University Hospital
Odense C, 5000, Denmark
Odense University Hospital - Svendborg Hospital
Svendborg, 5700, Denmark
Lillebaelt Hospital Vejle - University Hospital of Southern Denmark
Vejle, 7100, Denmark
Skåne University Hospital
Malmo, 205 02, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederik D Thrane, MD
Esbjerg Hospital - University Hospital of Southern Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
February 26, 2025
First Posted
March 19, 2025
Study Start
February 26, 2025
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2028
Last Updated
March 19, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR