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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT05972694
Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of Crohns disease. CD outpatients in remission
* Harvey Bradshaw-index in remission (\<6 score)
* Capable of providing consent to participate.
* Able to complete daily surveys and take oral nutrition
* Able to record daily meal intake
Exclusion Criteria:
* Short bowel syndrome.
* Hospitalized patients.
* Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
* Known drug abuse.
* Known parasitic disease of the digestive system.
* Symptomatic intestinal stricture.
* Presence of an ostomy.
* Other conditions that would be a contraindication to consumption of the study diets or preclude the participant from completing the study.
* Well-founded doubt about the patients cooperation.
* Existing pregnancy or lactation.
* History of \<1 natural bowel movements per day.
* Unable to access to technology that permits the daily completion of study related activities.
* Change in IBD medication within past 4 weeks.
* Body mass Index \<16 kg/m or ≥35.
* Documented C.difficile colitis within four weeks of screening.
* Known berry or grape allergy
* No probiotic or antibiotic use for the previous 14 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05972694
Study Brief:
Protocol Section:
NCT05972694