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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT05572203
Eligibility Criteria:
Inclusion Criteria for Healthy group
1. Aged 18 years or older
2. BMI \<30 kg/m2/
3. No previous known bowel disease
4. Be able to provide written informed consent \& participate fully in all aspects of the study.
Inclusion Criteria for Crohn's group:
1. Aged 18 years or older.
2. BMI \<30 kg/m2
3. Documented diagnosis of CD previously confirmed by endoscopy and histology at least 2 years prior to enrolment.
4. Active CD defined as HBI \>4 and CRP \>5g/l or FCP \>250ug/g or as deemed through endoscopy or cross sectional imaging.
5. Previous biologic or immunosuppressant exposure
6. Previous CD-related intestinal surgery
7. Able to participate fully in all aspects of the study
8. Written informed consent obtained and documented
Exclusion Criteria for Healthy group
1. Aged 18 years or older
2. BMI \<30 kg/m2/
3. No previous known bowel disease
4. Be able to provide written informed consent \& participate fully in all aspects of the study.
Exclusion Criteria for Crohn's group
1. A current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis
2. A diagnosis of short-bowel syndrome
3. Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrolment, or use of any medications for HVs and CD, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study.
4. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study.
5. History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
6. Pregnancy or breastfeeding.
7. Contraindications for DEXAscanning e.g. x-ray within last 7 days.
8. Allergy to milk, , or casein
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05572203
Study Brief:
Protocol Section:
NCT05572203