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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT04982666
Eligibility Criteria:
Inclusion Criteria:
* 18 years or older.
* Have the capacity for informed consent.
* Subjects must carry a diagnosis of CD at time of enrollment; the CD diagnosis will be based on clinical impression and documentation of the treating physician.
* Have active symptoms based on sCDAI score of \> 175.
* Have active inflammation documented by either: a fecal calprotectin of \>150 µg/g; OR high sensitivity C-reactive protein (hs-CRP) \>5 mg/L; OR evidence of active inflammation on CT (Computer Tomography) or MR (Magnetic Resonance) enterography, based on discretion of reviewing radiologist; OR documentation of active Crohn's disease on colonoscopy, defined as SES-CD (Simple Endoscopic Score for Crohn's disease) score of 3 or greater.
* Patients may continue their currently prescribed, stable doses of medical therapy during the study duration.
* Ability to have no more than 2 drinks/day for men and 1 drink/day for women.
* Ability and willingness to adhere to one of the study diets.
Exclusion Criteria:
* Hospitalized patients.
* Disease activity score sCDAI \> 400
* Already following plant-based diet, FODMAP diet, or other nutritional trials.
* Have recent changes in medical therapy (no start or change in immunomodulator, natalizumab, or vedolizumab within 12 weeks; 5-ASA, anti-TNFα agent, ustekinumab, or tofacitinib within 8 weeks; or corticosteroids within 2 weeks of randomization).
* Have an ostomy or ileoanal pouch.
* Have known luminal stricture or stenosis that would preclude consumption of fresh fruits and vegetables.
* Plans for GI surgery within six weeks of enrollment.
* Pregnant, planning to become pregnant, or breastfeeding.
* Have other conditions such as diabetes or celiac disease that may impact ability to follow study diet.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04982666
Study Brief:
Protocol Section:
NCT04982666