200
Participants
Start Date
December 1, 2024
Primary Completion Date
August 1, 2026
Study Completion Date
March 1, 2027
Proposed study design and randomization scenarios
Present hypothetical study scenarios and assess willingness to be randomized based on the adapted 7-item Attitudes to Randomized Trials Questionnaire
Repeated measures of validated Inflammatory Bowel Disease Patient Reported Outcome Instruments
We will electronically administer Ulcerative Colitis (UC) and Crohn's Disease validated PRO instruments, including the daily symptom modules and weekly quality of life modules for 12 weeks to all 200 participants
Inflammatory marker collection and assessment for correlation with PRO responses and menstrual timing
In an Aim 3 sub study of 30% of participants, we will collect inflammatory markers commonly used to assess disease activity and risk of relapse in inflammatory bowel disease patients, including weekly blood samples of high sensitivity c-reactive protein (13 total) and monthly ferritin, albumin, and WBC, as well monthly stool specimens (4 total) for fecal calprotectin
University of Utah, Salt Lake City
University of Utah
OTHER