Trial Outcomes & Findings for The Impact of Circadian Misalignment on Colonic Barrier Homeostasis in Ulcerative Colitis (NCT NCT05180279)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

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.

Results posted on

2025-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Control 7-day sleep lab: Healthy Control participants (no ulcerative Colitis) will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not have a misaligned circadian rhythm. They will have two unprepped flexible sigmoidoscopies with rectal biopsy collection and stool collection at baseline and after misalignment. 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.	Ulcerative Colitis 7-day sleep lab: Participants with ulcerative colitis will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not have a misaligned circadian rhythm. They will have two unprepped flexible sigmoidoscopies with rectal biopsy collection and stool collection at baseline and after misalignment. 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
Overall Study STARTED	9	10
Overall Study COMPLETED	7	10
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Control n=7 Participants 7-day sleep lab: Healthy Control participants (no ulcerative colitis) will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not have a misaligned circadian rhythm. They will have two unprepped flexible sigmoidoscopies with rectal biopsy collection and stool collection at baseline and after misalignment. 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.	Ulcerative Colitis n=10 Participants 7-day sleep lab: Participants with ulcerative colitis will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not have a misaligned circadian rhythm. They will have two unprepped flexible sigmoidoscopies with rectal biopsy collection and stool collection at baseline and after misalignment. 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.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants	10 Participants n=4 Participants	17 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	32 years n=93 Participants	23.5 years n=4 Participants	24 years n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants
Race/Ethnicity, Customized Caucasian	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized African American	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized African	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	7 Participants n=93 Participants	10 Participants n=4 Participants	17 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Healthy Control n=7 Participants 7-day sleep lab: Healthy control participants (no ulcerative colitis) will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not have a misaligned circadian rhythm. They will have two unprepped flexible sigmoidoscopies with rectal biopsy collection and stool collection. Cycles will be shifted by 12 hours once on Day 3 of sleep lab and be discharged after an 8-hour sleep session on Day 7.	Ulcerative Colitis n=10 Participants 7-day sleep lab: Participants with ulcerative colitis will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not a have a misaligned circadian rhythm. 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
Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment Misalignment Misaligned Circadian Rhythm	23.05 hours Standard Deviation 0.48	22.65 hours Standard Deviation 1.88
Change in Dim Light Melatonin Onset (DLMO) From Baseline (Aligned) to Circadian Misalignment Misalignment Baseline Aligned Circadian Rhythm	20.72 hours Standard Deviation 0.52	20.45 hours Standard Deviation 1.08

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Healthy Control n=7 Participants 7-day sleep lab: Healthy control participants (no ulcerative colitis) will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not have a misaligned circadian rhythm. They will have two unprepped flexible sigmoidoscopies with rectal biopsy collection and stool collection. Cycles will be shifted by 12 hours once on Day 3 of sleep lab and be discharged after an 8-hour sleep session on Day 7.	Ulcerative Colitis n=10 Participants 7-day sleep lab: Participants with ulcerative colitis will stay in 7-day sleep lab where light exposure, diet, and activity will be closely monitored. Participants at baseline will not a have a misaligned circadian rhythm. 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
Change in Intestinal Permeability From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment Baseline Aligned Circadian Rhythm	0.053 % excretion of oral dose 12-24 hr urinar Standard Deviation 0.040	0.141 % excretion of oral dose 12-24 hr urinar Standard Deviation 0.065
Change in Intestinal Permeability From Baseline (Aligned Circadian Rhythms) to Circadian Misalignment Misaligned Circadian Rhythm	0.088 % excretion of oral dose 12-24 hr urinar Standard Deviation 0.053	0.184 % excretion of oral dose 12-24 hr urinar Standard Deviation 0.111

SECONDARY outcome

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

Spectrophotometry

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Once before sleep lab

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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Weeks prior to circadian lab assessments

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

Outcome measures

Outcome data not reported

Adverse Events

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ulcerative Colitis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Garth Swanson

Medical University of South Carolina

Phone: 843-876-2152

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place