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:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-26 @ 10:32 AM
NCT ID:
NCT05627128
Eligibility Criteria:
Inclusion Criteria:
* 21 to 65 years old
* Confirmed CD diagnosis with sCDAI \<450 (includes values ranging from remission, mild to moderate activity)
* Moderate to severe impaired QoL (sIBDQ\<60)
* Stable doses of medications are screened; thiopurines, natalizumab, methotrexate (12 weeks), anti-tumor necrosis factor (TNF), ustekinumab, vedolizumab (8 weeks), 5-aminosalicylic acid (5-ASA) (2 weeks), steroids (1 week)
* Willingness and capacity to significantly change diet (arm 1)
* Willing and able to comply with specimen collection and other study procedures, and to complete the study
Exclusion Criteria:
* Ostomy
* Use of Specific Carbohydrate Diet of IBD-AID™ within 4 weeks of screening
* Use of prescribed probiotics within 4 weeks of screening
* \> 20mg prednisone or equivalent
* Recent C. difficile colitis
* Pregnancy
* Presence of symptomatic or significant structure or history of obstruction in the past 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT05627128
Study Brief:
Protocol Section:
NCT05627128