N/A
N=19
The Impact of Circadian Misalignment on Colonic Barrier Homeostasis in Ulcerative Colitis
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT05180279 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment Misalignment — 20.72; 20.45; 23.05; 22.65 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 7-day sleep lab (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment Misalignment |
20.72; 20.45; 23.05; 22.65 | — |
| PRIMARY Change in Intestinal Permeability From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment |
0.053; 0.141; 0.088; 0.184 | — |
| SECONDARY Change in 24 Hour Urinary Melatonin Concentrations From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment |
— | — |
| SECONDARY Change in Mayo Score From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment |
— | — |
| SECONDARY Change in Stool Calprotectin From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment |
— | — |
| SECONDARY Change in Concentration of Serum Cytokine Markers of Inflammation From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment |
— | — |
| SECONDARY Changes in Clock Gene Expression in Peripheral Blood Mononuclear Cells From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment |
— | — |
| SECONDARY Changes in Gene Expression of Colonic Tissue Biopsies From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment |
— | — |
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 Criteria
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
Data sourced from ClinicalTrials.gov (NCT05180279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.