Circadian Misalignment in Inflammatory Bowel Disease

NCT04637399 | Completed

• 1 other identifier: 16080305
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (10)

• Harvey Bradshaw Activity Index

  Disease Activity: Score 0-4

  1 Day

• Beck's Depression Index

  Score: 0-14

  Past Two Weeks from Date of Visit

• International Restless Leg Syndrome Scale

  Score 0-14

  Past Week from Date of Visit

• Berlin OSA Questionnaire

  Meet 0-1 Category

  Past 3 Months

• Short Inflammatory Bowel Disease Questionnaire

  Score: 1-7

  Past Two Weeks from Date of Visit

• Munich Chronotype Questionnaire

  Typical Sleep and Wake Habits

  Past 3 Months

• Owl and Lark Questionnaire

  Extreme morning type 70-86 Moderately morning type 59-69 Neutral type 42-58 Moderately evening type 31-41 Extreme evening type 16-30

  Past 3 Months

• ActiWatch

  Sleep-Wake Activity Wrist Monitor

  14 Day Period

• Food Timing Questionnaire

  Food and Sleep Habit Diary

  14 Day Period

• Sleep Diary

  Sleep Record

  14 Day Period

Secondary Outcomes (3)

• Urine Samples

  1 Day

• C-Reactive Protein

  10 Weeks +/- 3 Days

• Left Sided Colon Tissue Samples

  1 Day

Study Arms (2)

Ulcerative Colitis

Participants diagnoses with Ulcerative Colitis.

Crohn's Disease

Participants diagnosed with Crohn's Disease.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults diagnosed with Ulcerative Colitis or Crohn's Disease.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (46)

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Related Links

• Randomised clinical trial: Deep remission in biologic and immunomodulator naïve patients with crohn's disease - a SONIC post hoc analysis. - PubMed - NCBI \[homepage on the Internet\]. \[cited 6/9/2016\].

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Garth Swanson, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: November 19, 2020
• Study Start: November 22, 2016
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

US (1)