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The Impact of Circadian Misalignment on Colonic Barrier Homeostasis in Ulcerative Colitis | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT05180279•Rush University Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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
+22 more criteria

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States

Key Dates

Start Date

April 1, 2021

Primary Completion Date

June 5, 2024

Completion Date

June 5, 2024

Last Updated

August 19, 2025

Enrollment

ACTUAL participants

Conditions

Ulcerative Colitis

Interventions

7-day sleep lab

BEHAVIORAL

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069

Ulcerative Colitis (UC)

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RECRUITINGPHASE2

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

NCT06975722

Ulcerative Colitis

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RECRUITINGPHASE3

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis

A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)

ALPCO/Calprotectin CLIA Assay: Expected Values of Calprotectin in Healthy Subjects