Status:
ACTIVE_NOT_RECRUITING
Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Study will include individuals that are;
- M/F, 18-65 years of age
- Ulcerative Colitis with Inactive Disease (Mayo Score ≤ 2; partial Mayo Score ≤ 1 with endoscopic score 0-1)
- Subclinical inflammation stool calprotectin \> 50 or CRP \> mg/L above the upper limit of normal or PROMIS Fatigue Score ≥ 50)
- Stable medications with no disease flares for the \> 3 months,
Exclusion
- Study will not include individuals that are;
- Active UC at enrollment (Mayo \> 2 and/or sigmoidoscopy score of 2 or 3)
- 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
- Use of biologics or immunomodulatory medications ( i.e. infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.)
- Prior ostomy or subtotal colectomy
- Recent prednisone or antibiotic use in last 12 weeks
- Major Depression identified as Beck Depression Inventory (score ≥21)
- Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale)
- Sleep apnea (score high risk ≥ 2 or more categories on the Berlin Questionnaire)
- Clinically significant diabetes (Hgb-A1c\>7)
- Regular use of medications that affect intestinal permeability, intestinal motility and/or NSAIDs 4 weeks prior to the study
- Clinically significant cardiac, renal (creatinine \> twice normal) or liver disease
- Alcohol use disorder (AUDIT\>8)
- Chronic use of illicit drugs
- Shift Work
- Inability to sign an informed consen
Key Trial Info
Start Date :
July 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05213234
Start Date
July 9 2021
End Date
March 31 2026
Last Update
December 11 2025
Active Locations (2)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60068
2
The Medical University of South Carolina
Charleston, South Carolina, United States, 29425