Crohn's DiseaseANDI-3NCT06882993
Feasibility of a Minimally Invasive Diagnostic Algorithm in Suspected Crohn's Disease
A study testing Panenteric capsule endoscopy, Ileocolonoscopy and MRI enterography in people with Crohn's Disease, run by Esbjerg Hospital - University Hospital of Southern Denmark at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Panenteric capsule endoscopy, Ileocolonoscopy and MRI enterography
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 26 Feb 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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 cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Denmark4 sites, 4 recruiting
- Recruiting
Esbjerg Hospital - University Hospital of Southern Denmark
Esbjerg, 6700
Michael D Jensen, MD, PhD, 0045 79183146, Michael.Dam.Jensen@rsyd.dk
- Recruiting
Odense University Hospital
Odense C, 5000
Frederik D Thrane, MD, 0045 65412755, Frederik.Drejer.Thrane2@rsyd.dk
- Recruiting
Odense University Hospital - Svendborg Hospital
Svendborg, 5700
Jakob Dahlrot, MD, PhD, 0045 63202000, Jakob.Dahlrot@rsyd.dk
- Recruiting
Lillebaelt Hospital Vejle - University Hospital of Southern Denmark
Vejle, 7100
Maiken T Jørgensen, MD, PhD, 0045 79406345, Maiken.T.Joergensen@rsyd.dk
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Malmö, 205 02
Gabriele W Johansson, MD, PhD, 0046 40338622, Gabriele.WurmJohansson@skane.se
About this study
Official title: 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
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:
Read more
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
- Conditions
- Crohn's Disease
- Being tested
- Panenteric capsule endoscopy, Ileocolonoscopy, MRI enterography, Small bowel capsule endoscopy
- Keywords
- capsule endoscopy, panenteric capsule endoscopy, Crohn&#39;s disease, inflammatory bowel disease
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panenteric capsule endoscopyDiagnostic test
Panenteric capsule endoscopy
IleocolonoscopyDiagnostic test
Endoscopic examination of the colon and terminal ileum after bowel preparation.
MRI enterographyDiagnostic test
MRI of the small bowel
Small bowel capsule endoscopyDiagnostic test
Capsule endoscopy of the small bowel
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive diagnostic algorithm | Experimental | Not described Receives: Diagnostic Test: Panenteric capsule endoscopy |
| Traditional work-up | Active comparator | Colonoscopy and either MRI enterography or small bowel capsule endoscopy Receives: Diagnostic Test: Ileocolonoscopy; Diagnostic Test: MRI enterography; Diagnostic Test: Small bowel capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after initial diagnostic procedure
Secondary outcomes (8)
Feasibility of pan-enteric CE
Number of patients with suspected CD examined with pan-enteric CE and the number of ICs avoided
Measured: After completion of follow-up (12 months)
Additional examinations
Need for additional examinations in the two randomization arms
Measured: After completion of follow-up (12 months)
Safety
Number of severe adverse events
Measured: After completion of follow-up (12 months)
Time to diagnosis
Time from referral or first diagnostic procedure to final diagnosis and treatment
Measured: After completion of follow-up (12 months)
Disease classification and medical treatments
Disease classification and medical treatments in the two randomization arms
Measured: After completion of follow-up (12 months)
Patient satisfaction
Difference in Gastrointestinal Endoscopy Satisfaction Questionnaire (GESQ) score
Measured: Immediately after initial diagnostic procedure
Costs
Expenditure on diagnostic procedures, treatment and loss of productivity
Measured: After completion of follow-up (12 months)
Artificial intelligence
Diagnostic utility of AI algorithms in detection of gastrointestinal pathology using pan-enteric CE - sensitivity, specificity, severity, prediction and impact on clinical decision making
Measured: Immediately after initial diagnostic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start26 Feb 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Svendborg Hospital, Skane University Hospital, Vejle Hospital
- Responsible party
- Principal investigator, Frederik Drejer Thrane, Esbjerg Hospital - University Hospital of Southern Denmark
- Investigators
- Frederik D Thrane, MD, Principal investigator, Esbjerg Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882993
- Sponsor's protocol ID
- 24/50881
- Acronym
- ANDI-3
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06882993
- Acronym / sponsor ID
- ANDI-3 / 24/50881
- Conditions
- Crohn's Disease
- Keywords
- capsule endoscopy, panenteric capsule endoscopy, Crohn&#39;s disease, inflammatory bowel disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, Svendborg Hospital, Skane University Hospital, Vejle Hospital
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive diagnostic algorithm | Experimental | Diagnostic Test: Panenteric capsule endoscopy |
| Traditional work-up | Active comparator | Diagnostic Test: Ileocolonoscopy, Diagnostic Test: MRI enterography, Diagnostic Test: Small bowel capsule endoscopyColonoscopy and either MRI enterography or small bowel capsule endoscopy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Clinical suspicion of CD*
- Age 18-40 years
- Signed informed consent
- Diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) and either
- C-reactive protein (CRP) > 5 mg/L
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panenteric capsule endoscopyPanenteric capsule endoscopy | Diagnostic test | Minimally invasive diagnostic algorithm |
| IleocolonoscopyEndoscopic examination of the colon and terminal ileum after bowel preparation. | Diagnostic test | Traditional work-up |
| MRI enterographyMRI of the small bowel | Diagnostic test | Traditional work-up |
| Small bowel capsule endoscopyCapsule endoscopy of the small bowel | Diagnostic test | Traditional work-up |
Primary outcome
Diagnostic completeness
Time frame: Immediately after initial diagnostic procedure
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
8 secondary outcomes
Feasibility of pan-enteric CE
Time frame: After completion of follow-up (12 months)
Additional examinations
Time frame: After completion of follow-up (12 months)
Safety
Time frame: After completion of follow-up (12 months)
Time to diagnosis
Time frame: After completion of follow-up (12 months)
Disease classification and medical treatments
Time frame: After completion of follow-up (12 months)
Patient satisfaction
Time frame: Immediately after initial diagnostic procedure
Costs
Time frame: After completion of follow-up (12 months)
Artificial intelligence
Time frame: Immediately after initial diagnostic procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frederik D Thrane, MD principal investigator
Esbjerg Hospital - University Hospital of Southern Denmark
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panenteric capsule endoscopy, Ileocolonoscopy and MRI enterography in people with Crohn's Disease, run by Esbjerg Hospital - University Hospital of Southern Denmark at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederik D Thrane, MD (0045 79183140, Frederik.Drejer.Thrane2@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic completeness (time frame: Immediately after initial diagnostic procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.