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Could taking your UC meds at the right time of day boost their power?

NCT ID NCT05213234

Disease control Sponsor: Rush University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether taking a common ulcerative colitis medication (5-ASA) at a specific time of day—morning or evening—can better reduce hidden inflammation. Thirty-two adults with inactive UC will try both timing schedules over three months. Researchers will measure inflammation markers, drug levels in the gut, and sleep patterns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
5-aminosalicylic acid (5-ASA) taken at different times of day
What this could lead to
If it works, this could show that simply changing when you take your medication can better control inflammation in ulcerative colitis.
What could go wrong
This is a small, early-phase trial with only 32 people. The benefit may be small or not apply to everyone. It does not test a new drug, just timing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2021

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Study will include individuals that are; 1. M/F, 18-65 years of age 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: Study will not include individuals that are; 1. Active UC at enrollment (Mayo \> 2 and/or sigmoidoscopy score of 2 or 3) 2. Regular use of suppositories or enemas within the last 3 months 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

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

  • Rush University Medical Center

    Chicago, Illinois, 60068, United States

  • The Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

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