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

NCT ID: NCT05180279

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-06-05

Brief 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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sleep Lab

Group Type: EXPERIMENTAL

7-day sleep lab

Intervention Type: 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.

Interventions

7-day sleep lab

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ali Keshavarzian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DK124280

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19051402

Identifier Type: -

Identifier Source: org_study_id