Status:
UNKNOWN
Diagnosis of Inflammatory Bowel Disease by Examining the Entire Bowel by Pan-intestinal Capsule Endoscopy
Lead Sponsor:
Robert Bosch Medical Center
Collaborating Sponsors:
Medtronic
Conditions:
Inflammatory Bowel Diseases
Morbus Crohn
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is to discover inflammatory changes in the gastrointestinal tract in adult patients with suspicion of a chronic inflammatory bowel disease (IBD) by examining the entire bowel, in...
Detailed Description
People who contact a gastroenterologist because of persistent complaints like abdominal pain or diarrhea are suspicious having an inflammatory bowel disease and maybe meet the eligibility requirements...
Eligibility Criteria
Inclusion
- 18 years or older
- Apply one of the following
- Chronic abdominal pain for at least 4 weeks, min. 3/10 points on a visual pain scale
- Persistent diarrhea, Stool frequency of at least 4 per day
- doctor visit due to the mentioned complaints
- Exclusion of an infectious genesis or coeliac disease by serological testing or duodenal biopsy, if necessary
- Consent to study participation
- Fecal calprotectin \> 50 µg/g
Exclusion
- Pregnancy
- metastasized malignoma
- terminal renal insufficiency, renal insufficiency requiring dialysis
- swallowing disorder
- age \< 18 years
- lack of consent
- infectious genesis of symptomps
- coeliac disease
- Relative contraindication:
- evidence of strictures, strictures or fistulas in the gastrointestinal tract in imaging or in high suggestive symptoms, e.g. Ileus
Key Trial Info
Start Date :
March 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04904224
Start Date
March 7 2021
End Date
March 31 2023
Last Update
May 27 2021
Active Locations (6)
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1
Praxis Gersemann
Ditzingen, Baden-Wurttemberg, Germany, 71254
2
Praxis Escher
Leonberg, Baden-Wurttemberg, Germany, 71229
3
Gastroenterologische Schwerpunktpraxis
Stuttgart, Baden-Wurttemberg, Germany, 70190
4
Robert Bosch Medical Center
Stuttgart, Baden-Wurttemberg, Germany, 70376