The hypothesis of this study is that appropriate time of day of administration of oral, once daily 5-ASA therapy in alignment with the host circadian rhythms will improve subclinical inflammation and microbial structure/function and increase mucosal 5-ASA levels. All subjects will be randomized to once daily 5-ASA medications at two different times of the day: between 06:00 - 10:00 h or 18:00 - 22:00 h. Three disease assessments will performed at: 1) enrollment just before randomization; 2) month 1, at the completion of first arm (Condition 1), and 3) month 3, after completion of the second arm (Condition 2). During these study time points, participants will be asked to complete questionnaires, track their 5-ASA medication usage, provide a stool sample, blood draw, urine test, collect saliva, wear a watch to measure sleep patterns, and complete a flexible sigmoidoscopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
Chronotherapy is a behavioral intervention that has the intended effect of maximizing therapeutic benefit of a drug by coordinating intake times and biological rhythms.
Rush University Medical Center
Chicago, Illinois, United States
The Medical University of South Carolina
Charleston, South Carolina, United States
Change in Stool Calprotectin from Baseline to Morning Medication Administration to Night Medication Administration
ELISA
Time frame: 10 minute stool collection at Baseline, 10 minute stool collection at Morning Medication Administration, and 10 minute stool collection at Night Medication Administration
Change in Mucosal 5-ASA Concentration from Baseline to Morning Medication Administration to Night Medication Administration
HPLC of tissue samples taken during flexible sigmoidoscopy at Baseline, Morning Medication Administration and Night Medication Administration
Time frame: 30 minute flexible sigmoidoscopy at Baseline, 30 minute flexible sigmoidoscopy at Morning Medication Administration, and 30 minute flexible sigmoidoscopy at Night Medication Administration
Change in Intestinal Permeability from Baseline to Morning Medication Administration to Night Medication Administration
Intestinal permeability is assessed through spectrophotometric measurements of sucralose, sucrose, maltose and lactulose concentrations in urine following ingestion of a sugar cocktail.
Time frame: 24 hour urine collection at baseline, 24 hour urine collection at Morning Medication Administration, and 24 hour urine collection at Night Medication Administration
Change in Serum Cytokines from Baseline to Morning Medication Administration to Night Medication Administration
LBP, LPS, zonulin, and sCD14
Time frame: Single blood draw at baseline, single blood draw at Morning Medication Administration, and single blood draw at Night Medication Administration
Change in Mayo Score from Baseline to Morning Medication Administration to Night Medication Administration
Mayo Score
Time frame: 5 minute questionnaire at Baseline, 5 minute questionnaire at Morning Medication Administration, 5 minute questionnaire at Night Medication Administration
Change in Circadian Rhythms from Baseline to Morning Medication Administration to Night Medication Administration
Wrist Actigraphy
Time frame: Wrist Actigraphy Watch worn for two weeks at Baseline, two weeks at Morning Medication Administration, and two weeks at night medication administration
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