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:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT04370535
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers (at least 18 years old) for first two groups (A,B), homogenous starting group in age (30-60Y) and sex (m/f )
o The health-status will be confirmed through anamnesis.
* Groups C and D will include patients with confirmed Crohn's disease that are treated with standard therapy and despite of treatment do not achieve the appropriate disease remission. Patients with the intermediate type of disease will be also included in groups C and D.
* Diagnosis has to be confirmed with a biopsy of the intestine and histological exam.
* Degree of disease will be assessed by Harvey-Bradshaw Index (HBI). For evaluation of quality BDQ questionnaire will be used. For the assessment of disease activity ordinary laboratory measurements will be performed (CBC, basic biochemical parameters, CRP), and calprotectin from chairs. Colonoscopy must be done in the last six months prior to inclusion of patients in the research protocol. Gastrointestinal system degree of impairment will not have influence on inclusion criteria and patients with histological intermediate type of disease will be included as well.
* Signed informed consent as per usual recommendations in vigour in the Republic of Slovenia.
Exclusion Criteria:
* Signs of acute bacterial infection (fever \>38°C, nausea, vomiting).
* Other chronic disease (cancer, renal disease, neuro-degenerative, metabolic disorders, diabetic).
* Pregnancy or breastfeeding
* Food supplements\*\* \*\*NOTE: Food supplements: if taken regularly this should be continued also during the study and documented - otherwise a wash - out - phase would be necessary
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04370535
Study Brief:
Protocol Section:
NCT04370535