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Circadian Misalignment in Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04637399
Recruitment Status : Active, not recruiting
First Posted : November 19, 2020
Last Update Posted : November 19, 2020
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
This study is to explore the role the sleep/wake cycle (Circadian Rhythm) has on Inflammatory Bowel Disease. Participants will be asked to attend two clinic visits 14 days apart. Participants will complete a packet of questionnaires regarding their health and sleep habits. Over the 14 days between visits participants will be asked to wear a wrist actigraphy device that will measure their sleep-wake activity along with filling in a sleep diary. During the visits, participants will have a physical exam on visit 1 and on visit 2 participants will be asked to give blood, stool, and urine samples. Additionally, participants may also give sigmoid tissue samples during an optional unprepped limited flexible sigmoidoscopy procedure.

Condition or disease
Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis

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Study Type : Observational
Estimated Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circadian Misalignment as a Disease Risk Factor in Inflammatory Bowel Disease
Actual Study Start Date : November 22, 2016
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Ulcerative Colitis
Participants diagnoses with Ulcerative Colitis.
Crohn's Disease
Participants diagnosed with Crohn's Disease.

Primary Outcome Measures :
  1. Harvey Bradshaw Activity Index [ Time Frame: 1 Day ]
    Disease Activity: Score 0-4

  2. Beck's Depression Index [ Time Frame: Past Two Weeks from Date of Visit ]
    Score: 0-14

  3. International Restless Leg Syndrome Scale [ Time Frame: Past Week from Date of Visit ]
    Score 0-14

  4. Berlin OSA Questionnaire [ Time Frame: Past 3 Months ]
    Meet 0-1 Category

  5. Short Inflammatory Bowel Disease Questionnaire [ Time Frame: Past Two Weeks from Date of Visit ]
    Score: 1-7

  6. Munich Chronotype Questionnaire [ Time Frame: Past 3 Months ]
    Typical Sleep and Wake Habits

  7. Owl and Lark Questionnaire [ Time Frame: Past 3 Months ]
    Extreme morning type 70-86 Moderately morning type 59-69 Neutral type 42-58 Moderately evening type 31-41 Extreme evening type 16-30

  8. ActiWatch [ Time Frame: 14 Day Period ]
    Sleep-Wake Activity Wrist Monitor

  9. Food Timing Questionnaire [ Time Frame: 14 Day Period ]
    Food and Sleep Habit Diary

  10. Sleep Diary [ Time Frame: 14 Day Period ]
    Sleep Record

Secondary Outcome Measures :
  1. Urine Samples [ Time Frame: 1 Day ]
    Volume: First 5 hours, Second 19 hours, 24 hours

  2. C-Reactive Protein [ Time Frame: 10 Weeks +/- 3 Days ]
    milligrams per deciliter

  3. Left Sided Colon Tissue Samples [ Time Frame: 1 Day ]
    10 Double Bites with Forceps

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults diagnosed with Ulcerative Colitis or Crohn's Disease.

Inclusion Criteria:

  • Age of Diagnosis is < 40 years
  • Documented biopsy proven Crohn's Disease or Ulcerative Colitis
  • Willing to sign study consent form
  • At starting and during the study subject is free of prescription and over the counter medication that can affect melatonin over the past month: over the counter melatonin formulation, NSAID, alpha blocker, beta blocker, calcium channel blocker, benzodiazepine, hypnotic, barbiturate, antiepileptic, antidepressant, antipsychotic, metoclopramide

Exclusion Criteria:

  • Active IBD flare (HBI≥5)
  • Use of prednisone in the past 4 weeks
  • Other forms of colitis, such as indeterminate colitis
  • Moderate/severe depression or suicidal thoughts
  • Restless leg syndrome
  • Sleep apnea
  • Surgical history of ileostomy or colectomy with ileal pouch
  • Antibiotic use within the last 14 days prior to stool collection
  • Active or recent infection in the last 14 days prior to stool collection
  • Abnormal bleeding parameters (i.e., prolonged INR), history of easy bruising or bleeding (except rectal bleeding during flare-ups)
  • Psychiatric disorder (diagnosis reported or EMR)
  • Use of anticoagulants and anti-platelet drugs
  • Documented chronic disease (history or current) such as diabetes, lung, heart, eye, autoimmune, seizures, kidney (creatinine >1.2 mg/dL in last 12 months),or liver (AST/ALT >1.5x ULN in last 12 months)
  • Night shift work (3 or more nights/week) or more than 2 time zones crossed in past 4 weeks
  • Any children <2 years old living at home
  • WOMEN ONLY: Currently pregnant
  • Non-English speaking
  • Participating in other research studies involving research interventions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04637399

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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
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Principal Investigator: Garth Swanson, MD Rush University Medical Center
  Study Documents (Full-Text)

Documents provided by Rush University Medical Center:
Informed Consent Form  [PDF] October 17, 2018

Additional Information:
Singh S, Dera AE, Esteban JPG, Chakradeo PS, Lee AA, Burgess HR, Keshavarzian A, Swanson GR. Tu1992 later chronotype is associated with worse quality of life and biologic use in inflammatory bowel disease. Gastroenterology. 2016; 150(4): S999-S1000.

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Responsible Party: Rush University Medical Center Identifier: NCT04637399    
Other Study ID Numbers: 16080305
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases