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NCT05180279Completed

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

Source: ClinicalTrials.gov · Last updated 19 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
19 (actual)
First submitted
14 Dec 2021
Start date
1 Apr 2021
Primary completion date
5 Jun 2024
Lead sponsor
Rush University Medical Center
NCT number
NCT05180279

What you commit to

  • Study type: Interventional
  • Participants enrolled: 19
  • From 1 Apr 2021 to the primary completion date, 5 Jun 2024
  • 1 site 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 biologic or immunomodulatory medications (i.e. Infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.)
  • Gastrointestinal surgery
  • 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 weeks is needed before the subject could be enrolled into the study.
  • Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study.
  • Chronic Alcohol use. A washout period of 3 weeks is needed before the subject could be enrolled into the study.
  • Regular use of medications that affect intestinal permeability, intestinal motility and/or endogenous melatonin including metoclopramide, NSAIDs, antibiotics, beta blocker, psychotropic medication, hypnotics and exogenous melatonin products during 4 weeks prior to the study
  • People who crossed more than 2 time zones in the previous month

Other illness

  • Patients with other forms of colitis such as Crohn's disease (CD) or indeterminate colitis
  • Other GI diseases or systemic diseases (cardiac, renal failure, cirrhosis)

Lab values

  • History of drug abuse, gastrointestinal (GI) surgery, GI diseases, or systemic diseases such as renal (creatinine\>1.2 mg/dl), liver, cardiac, or diabetes (Hgb-A1c\>8%)

Other

  • UC patients:
  • Patient with active UC (Mayo \> 2)
  • Pancolonic UC (colitis past the splenic flexure, Montreal E3))
  • 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.
  • Have children under 6 months
    • Healthy Controls:
  • Antibiotic use within last 12 weeks
  • Shift work in the last 6 months
  • Use of probiotic supplement except yogurt in last 4 weeks.
  • Atypical American diet with daily fiber ≥ 16 grams or daily saturated fat ≤ 11 grams by Food Frequency Questionnaire
  • Significant Depression (score ≥ 14 BDI)
  • Significant Anxiety (score ≥ 40 STAI)
  • Inability to sign an informed consent form.
  • Have children under 6 months

Who the study is looking for

  • 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)

Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Rush University Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.