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Completed

NCT Number: NCT05180279

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 weeks is needed before the subject could be enrolled into the study.
  • Have children under 6 months

Healthy Controls:

  • 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%)
  • 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
  • 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.
  • Significant Depression (score ≥ 14 BDI)
  • Significant Anxiety (score ≥ 40 STAI)
  • 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
  • Inability to sign an informed consent form.
  • Have children under 6 months

Treatment and study plan

7-day sleep lab

Behavioral

Patients will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. They will have two unprepped flexible sigmoidoscopies with rectal biopsy collection and stool collection. Cycles will be shifted by 12h once on Day 3 of sleep lab and be discharged after an 8 hour sleep session on Day 7.

Primary outcomes

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

    Time frame: 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.

    Amount of time between dim light melatonin onset (DLMO) to sleep onset. The hours reported for this outcome measure equates the time of the day the participant fell asleep

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

    Time frame: 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

    Intestinal permeability is assessed through spectrophotometric measurements of sucralose, sucrose, maltose and lactulose concentrations in urine following ingestion of a sugar cocktail.

Secondary outcomes

  1. Change in 24 Hour Urinary Melatonin Concentrations From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment

    Time frame: 24 hour urine collection at baseline and 24 hour urine collection at circadian misalignment circadian

    Spectrophotometry

  2. Change in Mayo Score From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment

    Time frame: 30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment

    Within the endoscopic component of the Mayo Score, a score of 0 is given for normal mucosa or inactive UC, while a score of 1 is given for mild disease with evidence of mild friability, reduced vascular pattern, and mucosal erythema.

  3. Change in Stool Calprotectin From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment

    Time frame: 10 minute stool collection conducted at baseline circadian rhythm and at circadian misalignment.

    Calprotectin is a sensitive marker for inflammation in the gastrointestinal tract. Measured through enzyme linked immunosorbent assay for calprotectin in stool extract.

  4. Change in Concentration of Serum Cytokine Markers of Inflammation From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment

    Time frame: Blood is drawn every two hours over a 24 hour period at baseline (12 draws), and blood is drawn every two hours over a 24 hour period at circadian misalignment

    Enzyme linked immunosorbent assay

  5. Changes in Clock Gene Expression in Peripheral Blood Mononuclear Cells From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment

    Time frame: Blood is drawn every two hours over a 24 hour period at baseline (12 draws), and blood is drawn every two hours over a 24 hour period at circadian misalignment

    RNA Sequencing

  6. Changes in Gene Expression of Colonic Tissue Biopsies From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment

    Time frame: 30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment

    Tissue biopsies collected during flexible sigmoidoscopy conducted at Baseline Circadian Rhythm and at Circadian Misalignment. Assessed through histology and RNA Sequencing

Other outcomes

  1. Diet

    Time frame: Once before sleep lab

    Vioscreen Food Frequency Questionnaire (FFQ). Total of 19 measured food components. Vioscreen captures comprehensive dietary behaviors in just 30 minutes. It is a unique dietary questionnaire, management and analysis system that efficiently gathers and manages data that immediately identifies dietary "habits" and counsel for lifestyle changes.

  2. Single Day Food Recall

    Time frame: Once before sleep lab

    Automated Self-Administered 24-Hour Recall (ASA24) Dietary Assessment. Total nutrients from all supplements reported in a given day.

  3. Chronotype

    Time frame: Screening

    The Munich ChronoType Questionnaire (MCTQ) uses a self-rated scale to assess individual phase of entrainment on work and work-free days; it is a tool to collect primary sleep times, such as bed- and rise-times, plus the clock time of becoming fully awake as well as sleep latency and inertia, in addition to other time points.

  4. Beck Depression Inventory

    Time frame: 3 Weeks prior to circadian lab assessments

    The Beck Depression Inventory (BDI, BDI-II), created by Dr. Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.

  5. Pittsburgh Sleep Quality Index

    Time frame: 3 Weeks prior to circadian lab assessments

    The following questions relate to your usual sleep habits during the past month only.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2022
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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