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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT06419335
Eligibility Criteria:
Inclusion Criteria for all study participants
To be eligible for this study all study participants must meet the following:
1. Provide informed consent
2. Male or female, age 18-70
3. Ability to take an oral medication
4. Willingness and ability to do electronic surveys
Additional inclusion criteria for Cohort 1 and Cohort 2 participants:
1. Must have Crohn's disease for at least 3 months
2. Must be on stable medication regimen for Crohn's disease for at least 4 weeks
3. Clinically quiescent Crohn's disease based on the Patient Reported Outcome -Crohn's Disease (PRO2) average score for up to 7 days - daily liquid or very soft stool frequency of ≤1.5 and abdominal pain ≤1.0 5.3 Additional inclusion criteria for Cohort 1
1\. Prescreening PROMIS Fatigue 7a T score \>60 5.4 Additional inclusion criteria for Cohort 2 and 3
1\. Prescreening PROMIS Fatigue 7a T score \<55
Exclusion Criteria - for all study participants
1. Pregnant or lactating - a blood pregnancy test will be administered - fatigue is common with pregnancy and the post-partum period and is more likely to be unrelated to Crohn's
2. Chronic fatigue syndrome - noted in the medical record or self-reported
3. Depression as measured with PROMIS Depression scale 7a with T score \>=60
4. New York Heart Association (NYHA) class 3 or greater heart failure - if noted in the medical record
5. Untreated sleep apnea
6. Abnormal Thyroid Stimulating Hormone (TSH) - \<0.45 μlU/mL or \>5.33 μlU/mL
7. Iron deficiency or anemia - ferritin \< 20 without anemia or \<100 with anemia (hemoglobin \< 12g/dL in females or 13.5 g/dL in males) on the screening laboratory tests
8. B12 deficiency - \<180 pg/mL on the screening laboratory tests
9. Stage 3B or higher Chronic Kidney Disease (CKD) - based on an estimated glomerular filtration rate (eGFR) \< 45 ml/min on the screening laboratory tests
10. Diagnosis of cirrhosis - if noted in the medical record or self-reported
11. Diagnosis of primary sclerosing cholangitis
12. Diagnosis with hepatitis C without evidence of successful eradication
13. Cancer and receiving chemotherapy - if noted in the medical record or self-reported
14. Multiple Sclerosis - self-reported on in chart.
15. Taking systemic corticosteroids (e.g. prednisone or budesonide), not including single doses given to prevent adverse reactions to a medication or contrast agent
16. Taking warfarin - if noted in the medical record or self-reported
17. Diabetes requiring medication - if noted in the medical record or self-reported
18. Symptoms of an infection in the last 2 weeks - self-reported
19. Any other comorbidity or condition that the PI thinks is a contraindication to participation in this study
Exclusion Criteria for Cohorts 1 and 3
1\. Previous intolerance to CoQ10
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06419335
Study Brief:
Protocol Section:
NCT06419335