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Circadian Rhythm Adjustment for Ulcerative Colitis

N/A
Recruiting
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening
Awards & highlights

Study Summary

This trial will study if sleeping during the day (as opposed to at night) worsens gut inflammation in ulcerative colitis patients.

Who is the study for?
This trial is for men and women aged 18-50 with inactive Ulcerative Colitis (Mayo Score ≤ 2), who haven't had a disease flare in over three months. Healthy controls matched by age, sex, race, and BMI are also needed. Participants must not have significant depression or anxiety, recent antibiotic use, or a history of certain diets or medications that could affect the study.Check my eligibility
What is being tested?
The study examines if disrupted sleep patterns like night shifts can worsen gut inflammation in people with Ulcerative Colitis compared to healthy individuals. It involves spending seven days in a sleep lab to assess the impact on colonic barrier homeostasis.See study design
What are the potential side effects?
Since this trial involves monitoring sleep patterns rather than testing drugs, there are no direct medication side effects. However, participants may experience fatigue or stress due to changes in their usual sleeping habits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minute flexible sigmoidoscopy at baseline and 30 minute flexible sigmoidoscopy at circadian misalignment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minute flexible sigmoidoscopy at baseline and 30 minute flexible sigmoidoscopy at circadian misalignment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Intestinal Permeability from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
Change in the Phase Angle of Entrainment from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
Secondary outcome measures
Change in 24 hour Urinary Melatonin Concentrations from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
Change in Concentration of Serum Cytokine Markers of Inflammation from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
Change in Mayo Score from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
+3 more
Other outcome measures
Beck Depression Inventory
Berlin Questionnaire
Chronotype
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sleep LabExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
163,461 Total Patients Enrolled
4 Trials studying Ulcerative Colitis
224 Patients Enrolled for Ulcerative Colitis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,552 Total Patients Enrolled
13 Trials studying Ulcerative Colitis
2,112 Patients Enrolled for Ulcerative Colitis

Media Library

7-day sleep lab Clinical Trial Eligibility Overview. Trial Name: NCT05180279 — N/A
Ulcerative Colitis Research Study Groups: Sleep Lab
Ulcerative Colitis Clinical Trial 2023: 7-day sleep lab Highlights & Side Effects. Trial Name: NCT05180279 — N/A
7-day sleep lab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05180279 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims are being sought with this trial?

"With the primary aim being to evaluate changes in Intestinal Permeability over a predetermined time frame, this trial will involve 8 hours of hourly blood draws during baseline circadian rhythm and 12-hourly samples drawn when the patient's internal body clock is desynchronised. Secondary outcomes include RNA Sequencing for Clock Gene Expression in peripheral Blood Mononuclear Cells; Spectrophotometry for 24 hour Urinary Melatonin Concentrations; as well as within-Mayo Score evaluations which range from 0 (normal mucosa/inactive UC) to 1 (mild friability, reduced vascular pattern, mucosal erythema)."

Answered by AI

What is the current enrollment for this experiment?

"That is accurate. The information accessible through clinicaltrials.gov confirms that this experiment, posted on April 1st 2021, is currently recruiting patients. 40 participants need to be accepted from a single medical centre."

Answered by AI

Are there any restrictions on who can participate in this medical experiment?

"This clinical trial is currently enrolling 40 individuals with colitis or ulcerative that are between 18 and 50 years of age."

Answered by AI

Are people still being enrolled as participants in this experiment?

"The clinical trial is actively sourcing patients, as seen on the details found on clinicaltrials.gov. This study was initially published in April of 2021 and its parameters were most recently updated in October of 2022."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Rush University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Impact of Circadian Misalignment on Colonic Barrier Homeostasis in Ulcerative Colitis
Ali Keshavarzian 2021. "The Impact of Circadian Misalignment on Colonic Barrier Homeostasis in Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05180279.
All > Ulcerative Colitis > Colitis
~1 spots leftby Jun 2024
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