ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Timing of mesalamine might change how much drug reaches the colon, gut inflammation markers, and the microbiome — which could affect symptom control or monitoring for people with UC. This trial tests that idea in people with inactive disease but signs of low-level inflammation.
Understanding chronotherapy could lead to simple, low-cost changes (when you take medication) that modify treatment effect or biomarker interpretation.
Who Should Pay Attention
Adults with ulcerative colitis (inactive disease with subclinical inflammation); clinicians managing UC medication timing; researchers interested in chronotherapy, mucosal drug levels, biomarkers, or microbiome effects.
Study Snapshot
Story typeClinical Reference
Trial phaseNA
Enrollment32 participants
Study statusActive_not_recruiting
Source depthTrial registry record
What To Know
This ClinicalTrials.gov record describes an interventional study testing whether timing (chronotherapy) of once-daily oral 5-ASA (mesalamine) affects subclinical inflammation, mucosal drug levels, and microbiome measures in adults with inactive ulcerative colitis but evidence of subclinical inflammation.
Participants are randomized to take 5-ASA in the morning (06:00–10:00) versus the evening (18:00–22:00) with assessments at enrollment, 1 month, and 3 months that include questionnaires, stool and blood tests, saliva, a wearable sleep tracker, and flexible sigmoidoscopy with tissue sampling.
The study’s registered primary outcomes are change in fecal calprotectin and change in mucosal 5-ASA concentration between the dosing-time conditions. Planned enrollment is 32 adults; key exclusions include active UC, recent biologic or immunomodulator use, prior colectomy/ostomy, recent antibiotics or steroids, and shift work.
Keep In Mind
This entry is a trial record describing methods and planned outcomes rather than reported results. The study excludes people on biologics or with recent antibiotics/steroids and recruits a small number of participants, which limits generalizability. Flexible sigmoidoscopy is used for mucosal sampling; fecal calprotectin and CRP are key biomarkers. SummaryConfidence: medium.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorRush University Medical Center
Trial IDNCT05213234
Study typeInterventional
Trial phaseNA
Enrollment32 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedSep 30, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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