CompletedNot Applicable

The Impact of Circadian Misalignment on Colonic Barrier Homeostasis in Ulcerative Colitis

United States19 participantsStarted 2021-04-01

Plain-language summary

The purpose of this study is to investigate if circadian malalignment (unusual sleeping patterns), such as night shifts (sleeping during the day and being awake during the night time), worsens the inflammation of the gut. We hope to look at patients with Ulcerative Colitis and Healthy Controls.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: UC patients: * M/F, 18-50 y/o * Inactive Disease (Mayo Score ≤ 2) * Stable medications with no disease flares for the \> 3 months * Left-sided UC (Montreal E1 or E2) * Normal psychological evaluation and negative drug screen (See Below) Healthy Controls: * M/F, 18-50 y/o, age ± 3y sex, race, and BMI match with UC subject * No clinical evidence of any medical illness * Normal psychological evaluation and negative drug screen (See Below) Exclusion Criteria: UC patients: * Patients with other forms of colitis such as Crohn's disease (CD) or indeterminate colitis * Patient with active UC (Mayo \> 2) * Pancolonic UC (colitis past the splenic flexure, Montreal E3)) * Use of biologic or immunomodulatory medications (i.e. Infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.) * Gastrointestinal surgery * Other GI diseases or systemic diseases (cardiac, renal failure, cirrhosis) * Shift work in the last 6 months * Antibiotic use within last 12 weeks * Patients who have used anti-diarrheal agents such as Lomotil or Imodium within 3 days of the study * Prednisone use the last 30 days * Significant Depression (score ≥ 14 BDI) * Significant Anxiety (score ≥ 40 STAI) * Use of probiotic supplement in last 4 weeks except yogurt. * Intentional change in diet. * Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study. Low dose aspirin is allowed. * Chronic Alcohol use. A washout period of 3 week…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment Misalignment

Timeframe: Blood is drawn every hour over 8 hours to measure plasma melatonin in dim light < 5 lux in Aligned Circadian Rhythms, and blood is drawn every hour for 12 hours under dim light in Misaligned Circadian rhythms.

Change in Intestinal Permeability From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment

Timeframe: 24 hour urine collection beginning at baseline and 24 hour urine collection at circadian misalignment, an average of 3 days from baseline to circadian misalignment

Trial details

NCT IDNCT05180279

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-05

Results submitted2025-06-19

View on ClinicalTrials.gov More Ulcerative Colitis trials