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Ulcerative ColitisNCT05180279

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

A study testing 7-day sleep lab in people with Ulcerative Colitis, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Ulcerative Colitis
What is being tested?
7-day sleep lab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
1 Apr 2021to 5 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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)

Who cannot join

  • 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
Show all 32Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rush University Medical Center

    Chicago, Illinois, 60612

Other trials in United States

About this study

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.

Being tested
7-day sleep lab
Keywords
Circadian Rhythms
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 7-day sleep labBehavioural

    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.

Study groups in NCT05180279
Study groupRoleWhat they receive
Sleep LabExperimentalNot described
Receives: Behavioral: 7-day sleep lab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 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.

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

    Measured: 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

Secondary outcomes (6)

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

    Spectrophotometry

    Measured: 24 hour urine collection at baseline and 24 hour urine collection at circadian misalignment circadian

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

    Measured: 30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment

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

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

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

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

    Enzyme linked immunosorbent assay

    Measured: 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

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

    RNA Sequencing

    Measured: 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

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

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

    Measured: 30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start1 Apr 2021
  3. Primary completion5 Jun 2024
  4. Study completion5 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
40 human subjects will be recruited into this proposed study: 20 Healthy Controls and 20 UC subjects with left sided inactive disease. Patients will be matched with Health Controls. Patients will have two study visits: the first is the initial in-clinic screening and the second is the 7-day sleep lab intervention. There will be no follow-up after the lab.
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05180279
Sponsor's protocol ID
19051402
Other IDs
R01DK124280
Status last verified
Jul 2025
First submitted
14 Dec 2021
Last updated
19 Aug 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 7-day sleep lab in people with Ulcerative Colitis, run by Rush University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05180279.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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