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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT04100005
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients age 12 and older. (interest is given to children 12 and older to compare with mothers).
3. Diagnosis of Non-Fistulating Crohn's disease confirmed by at least one of the following
1. Colonoscopy
2. Capsule Endoscopy
3. Computerized Tomography (CT) Scan
4. Magnetic Resonance Imaging (MRI)
5. Balloon-assisted enteroscopy
Exclusion Criteria:
1. Refusal to sign informed consent form
2. Presence of Fistulating Crohn's disease
3. Treatment with antibiotics within 2 weeks prior to screening
4. Treatment with probiotics within 6 weeks prior to screening.
5. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
6. Postoperative stoma, ostomy, or ileoanal pouch
7. Participation in any experimental drug protocol within the past 12 weeks
8. Treatment with total parenteral nutrition
9. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
10. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04100005
Study Brief:
Protocol Section:
NCT04100005