Chronotherapy in Inflammatory Bowel Disease

• Status: Recruiting
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to determine if there is any difference in the efficacy of Inflammatory Bowel Disease (IBD) medication and disease outcomes when taken in the morning or in the evening. The IBD medications being observed are azathioprine and 6-mercaptopurine. The study team believes that there may be a benefit to taking the medication at a certain time of day. To test this theory the study asks participants who are already taking either azathioprine or 6-mercaptopurine for IBD to take the medication consistently at either the morning or in the evening based on when they currently take their medication. Participation is up to 10 weeks +/- 3 days. There will be 2 study visits where the participant will be asked to fill in questionnaires related to their IBD symptoms, their sleep habits, sleep quality, and general health information followed by a blood draw.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Azathioprine; Mercaptopurine

Criteria

Inclusion Criteria:

• Above the ages of 18

• Diagnosis of Crohn's Disease or Ulcerative Colitis

• Currently taking azathioprine or 6-mercaptopurine

• Willing to sign study consent form

Exclusion Criteria:

• Vulnerable population (pregnant, prisoner, non-English speaking or cognitively impaired)

• Breastfeeding subject

• Have a history of complications related to immunomodulatory therapy

• Participating in other research studies involving research interventions

• Treated with dual corticosteroid and immunomodulatory therapy