Advanced Non-Invasive Diagnostics in Inflammatory Bowel Disease

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages 15 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 information - Colonoscopy contraindicated, performed within 3 months or unwillingness to go through colonoscopy

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03134586

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Sydvestjysk Hospital

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOtherOther
Overall Status Recruiting
Countries Denmark

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Crohn Disease
Additional Details

This is a prospective, blinded, multicenter study of the diagnostic validity, inter-observer agreement, image quality and subjective experience of discomfort with PCCE, MREC and US in patients with suspected CD. Ileocolonoscopy serves as the diagnostic gold standard. Patients are recruited from 3 centers in the Region of Southern Denmark managing adult patients with inflammatory bowel diseases. Each patient goes through a standardized work-up including medical history, physical examination, C-reactive protein, fecal calprotectin, ileocolonoscopy, PCCE, MREC and US. All examinations are reviewed and described in a standardized fashion. The radiologists and physicians describing PCCE, MREC, and US are blinded to the findings at ileocolonoscopy and the other imaging modalities.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sydvestjysk sygehus, Esbjerg, Denmark

Status

Recruiting

Address

Sydvestjysk sygehus

Esbjerg, , DK-6700

Site Contact

Jacob B Brodersen, MD

jacob.broder.brodersen@rsyd.dk

+45 21298001

Odense university Hospital, Odense, Denmark

Status

Recruiting

Address

Odense university Hospital

Odense, , DK-5000

Site Contact

Jens Kjeldsen, MD, PhD

+45 21298001

Sygehus Lillebaelt, Vejle, Denmark

Status

Recruiting

Address

Sygehus Lillebaelt

Vejle, , DK-7100

Site Contact

Michael D Jensen, MD, PhD

+45 21298001

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