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

NCT05180279 | Completed Results

• 2 other identifiers: 19051402R01DK124280
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Keywords

Circadian Rhythms

Outcome Measures

Primary Outcomes (2)

• 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

  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.

• 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.

  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)

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

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

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

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

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

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

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

  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

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

  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

Other Outcomes (5)

• Diet

  Once before sleep lab

• Single Day Food Recall

  Once before sleep lab

• Chronotype

  Screening

Study Arms (1)

Sleep Lab

EXPERIMENTAL

Behavioral: 7-day sleep lab

Interventions

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.

Sleep Lab

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Dr Garth Swanson
• Organization: Medical University of South Carolina

swansong@musc.edu

843-876-2152

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 6, 2022
• Study Start: April 1, 2021
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-07

Locations

US (1)