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 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT06890650
Eligibility Criteria:
Inclusion Criteria:
1. Patients with treatment-naive Crohns disease accessible with ileocolonoscopy
2. Symptom onset of less than 12 months
3. Mild to moderate disease activity with endoscopically active disease
1. CDAI of greater than 150 and less than 450
2. SES-CD of or equal to or greater than 6 (or equal to or greater than 4 if isolated ileal disease)
4. Aged between 18-75 years
Exclusion Criteria:
1. Patients with severe disease (CDAI greater than 450, SES-CD greater than 16) or requiring hospitalization
2. Patients who have been received on corticosteroids, immunosuppressants (azathioprine/ 6- mercaptoprine/methotrexate) for greater than 2 weeks
3. Biologicals or small molecule exposure
4. Stricturing (non-passable stricture), fistulising phenotype or perianal fistula/abscess
5. L4 disease
6. Pregnant or lactating women
7. Previous surgery for CD
8. Declining consent
9. Not willing for FMT/Dietary advise
10. Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
11. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
12. Patients infected with human immunodeficiency virus (HIV) # The patients with positive assay will be treated appropriately and tests will be repeated. Those with negative assay and persistent activity will be included in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06890650
Study Brief:
Protocol Section:
NCT06890650