Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT02245594
Eligibility Criteria:
Inclusion Criteria:
* Patients with CD based on accepted endoscopic and histological criteria (according to ECCO guidelines (17) )
* Age ≥18 years
* A minimum disease duration of five years
* Remission defined by Faecal calprotectin \< 100 and CRP level within normal values for a minimum of 1 month
* Baseline values:
* CRP normal
* Faecal calprotectin \< 100
* Ileocoecal and/or colic localization of disease (Montreal phenotype classification)
* One or more IBS-like-symptoms (abdominal pain and discomfort, diarrhea, constipation)
Exclusion Criteria:
* Stricturizing CD
* Obvious stenotic symptoms
* Previous major gastrointestinal surgery
* Diagnosis of other gastrointestinal diseases affecting motility (ex. Coeliac disease)
* Medication altering gastrointestinal motility
* Hepatobiliary disease (PSC)
* Diabetes Mellitus
* Metabolic disorder
* Bacterial overgrowth (hydrogen breath test)
* Planned MR scan in the four weeks following capsule intake (safety precaution)
* Abdominal diameter \> 140 cm
* Implanted electronic devices (pacemaker, ICD, etc.)
* Diagnosed sleep disorder
* Pregnancy and breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02245594
Study Brief:
Protocol Section:
NCT02245594