NCT05213234Active, not recruiting
Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis
Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis: A Randomized Crossover Trial
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 9 Dec 2021
- Start date
- 9 Jul 2021
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Rush University Medical Center
- Diseases
- Ulcerative colitis
- NCT number
- NCT05213234
What you commit to
- Study type: Interventional
- Planned participants: 32
- From 9 Jul 2021 to the primary completion date, 30 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of biologics or immunomodulatory medications ( i.e. infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.)
- Prior ostomy or subtotal colectomy
- Regular use of medications that affect intestinal permeability, intestinal motility and/or NSAIDs 4 weeks prior to the study
- Chronic use of illicit drugs
Other illness
- Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale)
- Clinically significant diabetes (Hgb-A1c\>7)
- Alcohol use disorder (AUDIT\>8)
Lab values
- Clinically significant cardiac, renal (creatinine \> twice normal) or liver disease
Other
- 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
- Recent prednisone or antibiotic use in last 12 weeks
- Major Depression identified as Beck Depression Inventory (score ≥21)
- Sleep apnea (score high risk ≥ 2 or more categories on the Berlin Questionnaire)
- Shift Work
- Inability to sign an informed consen
Who the study is looking for
- 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,
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.