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 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT07086833
Eligibility Criteria:
Inclusion Criteria:
* Aged 45-75
* Up to date with CRC screening colonoscopy with a high risk of CRC, defined as a history of 3 or more adenomatous polyps (APs) or an AP \>1 cm in the past 5 years
* Identify as Black or Non-Hispanic White
* If female, no menstrual period for at least six months
* Willingness to donate oral wash and stool samples
* Willingness to complete 24-hour dietary recalls
Exclusion Criteria:
* Antibiotic use within the last 6 months
* Abnormal gastrointestinal transit
* A history of organ transplantation
* Use of illicit drugs, combustible tobacco, or dietary supplements
* Pre- or probiotics within the last two months
* A history of cancer treatment within the past 12 months
* CRC or a genetic predisposition to CRC
* A baseline body weight \> 450 lbs
* Weight gain or loss \> 4 kg 3 months prior to study
* Significant food allergies, food preferences or therapeutic or vegetarian diets
* Menstrual cycle within the last 6 months
* Antibiotics in the last 2 months
* Cannot keep a food record for 7 consecutive days during screening after detailed instruction
* Significant medical conditions
* History of eating disorders
* Alcoholism
* Individuals under the age of 18
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT07086833
Study Brief:
Protocol Section:
NCT07086833