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7-day sleep lab for Ulcerative Colitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ulcerative Colitis7-day sleep lab - Behavioral
Eligibility
18 - 50
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Hydroxychloroquine
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Lyophilized fecal microbiota (LFMT)

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Screening

10 minute stool collection conducted at baseline circadian rhythm and at circadian misalignment.
Change in Stool Calprotectin from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
Hour 24
Change in 24 hour Urinary Melatonin Concentrations from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
Hour 24
Change in Intestinal Permeability from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
Week 3
Beck Depression Inventory
Pittsburgh Sleep Quality Index
30 minute flexible sigmoidoscopy at Baseline and 30 minute flexible sigmoidoscopy at Circadian Misalignment
Change in Mayo Score from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
Changes in Gene Expression of Colonic Tissue Biopsies from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
Blood drawn hourly for eight hours at baseline circadian rhythm (eight draws) and blood drawn hourly for twelve hours at circadian misalignment (12 draws).
Change in the Phase Angle of Entrainment from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
Hour 24
Change in Concentration of Serum Cytokine Markers of Inflammation from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
Changes in Clock Gene Expression in Peripheral Blood Mononuclear Cells from Baseline (Aligned Circadian Rhythms) to Circadian Misalignment
Once before sleep lab
Diet
Single day food recall
Screening
Berlin Questionnaire
Chronotype
Inflammatory Bowel Disease Questionnaire
Perceived Stress Questionnaire
The International Restless Legs Syndrome Study Group Rating Scale
The State-Trait Anxiety Inventory

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
PL8177
1
Hydroxychloroquine
2
Lyophilized fecal microbiota (LFMT)

Trial Design

1 Treatment Group

Sleep Lab
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: 7-day sleep lab · No Placebo Group · N/A

Sleep Lab
Behavioral
Experimental Group · 1 Intervention: 7-day sleep lab · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: screening

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
389 Previous Clinical Trials
153,457 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
2,144 Previous Clinical Trials
4,064,534 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
1,833 Patients Enrolled for Ulcerative Colitis

Eligibility Criteria

Age 18 - 50 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an inactive disease (Mayo Score ≤ 2).

Who else is applying?

What state do they live in?
Illinois100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Rush University Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

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