Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis
NCT ID: NCT05213234
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
32 participants
INTERVENTIONAL
2021-07-09
2026-03-31
Brief Summary
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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 3, at the completion of first arm (Condition 1), and 3) month 6, 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Morning Medication Administration
Subjects are directed to take their medication between 06:00 and 10:00.
Chronotherapy
Chronotherapy is a behavioral intervention that has the intended effect of maximizing therapeutic benefit of a drug by coordinating intake times and biological rhythms.
Night Medication Administration
Subjects are directed to take their medication between 18:00 and 22:00.
Chronotherapy
Chronotherapy is a behavioral intervention that has the intended effect of maximizing therapeutic benefit of a drug by coordinating intake times and biological rhythms.
Interventions
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Chronotherapy
Chronotherapy is a behavioral intervention that has the intended effect of maximizing therapeutic benefit of a drug by coordinating intake times and biological rhythms.
Eligibility Criteria
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Inclusion Criteria
2. Ulcerative Colitis with Inactive Disease (Mayo Score ≤ 2; partial Mayo Score ≤ 1 with endoscopic score 0-1)
3. Subclinical inflammation stool calprotectin \> 50 or CRP \> mg/L above the upper limit of normal or PROMIS Fatigue Score ≥ 50)
4. Stable medications with no disease flares for the \> 3 months,
Exclusion Criteria
2. Regular use of suppositories or enemas within the last 3 months ORA: 20052807-IRB01 Date IRB Approved: 11/6/2023 Amendment Date: 4/7/2024 Protocol Version Date: 4/4/2024 7
3. Use of biologics or immunomodulatory medications ( i.e. infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.)
4. Prior ostomy or subtotal colectomy
5. Recent prednisone or antibiotic use in last 12 weeks
6. Major Depression identified as Beck Depression Inventory (score ≥21)
7. Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale)
8. Sleep apnea (score high risk ≥ 2 or more categories on the Berlin Questionnaire)
9. Clinically significant diabetes (Hgb-A1c\>7)
10. Regular use of medications that affect intestinal permeability, intestinal motility and/or NSAIDs 4 weeks prior to the study
11. Clinically significant cardiac, renal (creatinine \> twice normal) or liver disease
12. Alcohol use disorder (AUDIT\>8)
13. Chronic use of illicit drugs
14. Shift Work
15. Inability to sign an informed consen
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Rush University Medical Center
OTHER
Responsible Party
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Ali Keshavarzian
Chief of the Section of Gastroenterology
Locations
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Rush University Medical Center
Chicago, Illinois, United States
The Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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20052807
Identifier Type: -
Identifier Source: org_study_id
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