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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT04303260
Eligibility Criteria:
Inclusion Criteria:
1. 18 \< age \< 60
2. Clinically stable patients, constant medicinal regimen throughout the study period. Refractory to mesalamine at least 6 weeks, or steroids at least 2 week, or immunomodulator at least 12 weeks or biologics at least 12 weeks therapy, medical cannabis at least 2 weeks before the study.
3. CD patients will be included if their symptoms score 5≤ between ≤15 on the Harvey-Bradshaw index (HBI) score
4. UC patients will be included if their symptoms score 3≤between≤9 on the Simple Clinical Colitis Activity Index (SCCAI)
Exclusion Criteria:
1. Inability to commit for performing at least 15 minutes of exercise, 6 times a week
2. Lack of availability or capability to use a computer/ internet.
3. Any proven current infection such as Clostridium difficile infection, positive stool culture, or parasites.
4. Inability to sign informed consent and complete study protocol
5. Pregnancy
6. Subjects with chronic conditions such as cancer, organ transplant subjects, advanced kidney or liver disease, systemic inflammatory conditions other than IBD.
7. Patients with ileostomy, pouch or short bowel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04303260
Study Brief:
Protocol Section:
NCT04303260