Inflammatory Bowel DiseasesNCT04637399
Circadian Misalignment in Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2016to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults diagnosed with Ulcerative Colitis or Crohn's Disease.
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Circadian Misalignment as a Disease Risk Factor in Inflammatory Bowel Disease
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.
Read the detailed description
The long term goal of this Research proposal is to establish that circadian misalignment is a factor for disease flare in inflammatory bowel disease (IBD). In order to achieve this goal this project will focus on two aspects that are critical to address in the management of IBD - disease course and subclinical inflammation. One of the most challenging aspects of IBD medical care is that IBD has a very heterogeneous disease course. Some patients will quickly progress to surgery despite aggressive medical therapy while others have no disease flares on any medications. In order to address these factors, the investigator will access multiple factors about each IBD patient to determine what their previous disease course has been (history), known factors of their disease that are associated with disease course (location, age of diagnosis, etc), and markers of subclinical inflammation that are established predictors of disease flare. Our overall hypothesis is that circadian misalignment is an important factor in the disease course in IBD. To test this hypothesis, the investigator will conduct a series of experiments in humans to elucidate the role of circadian rhythms in IBD. In Aim 1, the investigator will test the hypothesis that circadian misalignment is present in IBD with an aggressive disease course by analyzing circadian rhythms by wrist actigraphy, urinary melatonin, and chronotype questionnaires. In Aim 2, the investigator will assess markers of subclinical inflammation in the same subjects from Aim1, and analyze established predictors of disease flare such as CRP, intestinal permeability, fecal calprotectin, and mucosal inflammation markers. The goal of this research proposal is to identify whether circadian misalignment is a factor in disease course in IBD. It is not to determine if IBD patients have increased circadian misalignment compared to healthy controls, therefore healthy controls are not used as a comparison group. However, Dr. Burgess and Dr. Levi's labs do have a large historical cohort of over 100 healthy controls that have completed wrist actigraphy measurements and chronotype questionnaires that can be used as a comparison if our hypothesis is proven incorrect.
Experimental Design: Subjects with biopsy proven IBD (N=68) will be recruited, 24 CD (Crohn's Disease) and 24 UC (Ulcerative Colitis). All subjects will be between 18-70 years old. Subjects will be recruited from the Rush University GI Clinic. All subjects will complete questionnaires including IBD demographic history, an IBD quality of life, food timing, sleep questionnaires - PROMIS and RUSATED, and chronotype questionnaires - Owl and Lark and Munich. Each subject will be accessed by the PI for exclusion criteria including: 1) Active IBD (HBI ≥ 5 or Modified HBI ≥5); 2) Major depression (score ≥ 15 or any endorsement of suicidal intent on the Beck Depression; 3) Sleep apnea (score high risk ≥ 2 or more categories on the Berlin Questionnaire)(43); 4) Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44)); 5) Regular use of medications that affect intestinal permeability, and/or endogenous melatonin including metoclopramide, NSAIDs, beta blocker, psychotropic medication, hypnotics and exogenous melatonin products during 4 weeks prior to the study; 6) People who have worked night shifts or crossed more than 2 time zones in the previous month; 7) Any major organ disease - renal impairment (creatinine>1.2 mg/dL - previous EMR labs must be within the past 12 months), diabetes (Hgb-A1c > 6.5% - no history of any form of diabetes); liver disease (LFTs > 1.5x nl - previous EMR labs must be within the past 12 months), or significant cardiac problems; 8) Inability to sign an informed consent.
Subjects that meet these inclusion/exclusion criteria will be assessed by the PI, who will perform a physical exam, take a history, and review prior medical testing. Subjects will matched 1:1 during recruitment so N=12 in both CD and UC with aggressive disease and N=12 in both CD and UC with nonaggressive disease (See Experimental Design). All subjects will then have their sleep patterns recorded by wrist actigraphy (30 sec epochs, Actiwatch Spectrum, Phillips Inc.) for 14 days (±3 days). Wrist actigraphy is a reliable standard means of assessing sleep-wake activity,(45) and will be used to calculate circadian rhythm by dichotomy index and r24. During the 14days (±3 days) subjects will also keep a detailed consensus sleep diary which is a standardized prospective sleep measure.(46) At the end of the 14 days (±3 days), and a day prior to their visit, all subjects will complete an online self-administered 24 hour food recall (ASA24) and 24 h urine collection for urinary melatonin which is also a marker of central circadian rhythm.
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis | Participants diagnoses with Ulcerative Colitis. | |
| Crohn's Disease | Participants diagnosed with Crohn's Disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harvey Bradshaw Activity Index
Disease Activity: Score 0-4
Measured: 1 Day
Beck's Depression Index
Score: 0-14
Measured: Past Two Weeks from Date of Visit
International Restless Leg Syndrome Scale
Score 0-14
Measured: Past Week from Date of Visit
Berlin OSA Questionnaire
Meet 0-1 Category
Measured: Past 3 Months
Short Inflammatory Bowel Disease Questionnaire
Score: 1-7
Measured: Past Two Weeks from Date of Visit
Munich Chronotype Questionnaire
Typical Sleep and Wake Habits
Measured: 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
Measured: Past 3 Months
ActiWatch
Sleep-Wake Activity Wrist Monitor
Measured: 14 Day Period
Food Timing Questionnaire
Food and Sleep Habit Diary
Measured: 14 Day Period
Sleep Diary
Sleep Record
Measured: 14 Day Period
Secondary outcomes (3)
Urine Samples
Volume: First 5 hours, Second 19 hours, 24 hours
Measured: 1 Day
C-Reactive Protein
milligrams per deciliter
Measured: 10 Weeks +/- 3 Days
Left Sided Colon Tissue Samples
10 Double Bites with Forceps
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start22 Nov 2016
- Primary completionNov 2021
- Study completionNov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garth Swanson, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637399
- Sponsor's protocol ID
- 16080305
- Status last verified
- Jun 2022
- First submitted
- 6 Aug 2019
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kappelman MD, Rifas-Shiman SL, Porter CQ, Ollendorf DA, Sandler RS, Galanko JA, Finkelstein JA. Direct health care costs of Crohn's disease and ulcerative colitis in US children and adults. Gastroenterology. 2008 Dec;135(6):1907-13. doi: 10.1053/j.gastro.2008.09.012. Epub 2008 Sep 17.
PubMed 18854185Keefer L, Stepanski EJ, Ranjbaran Z, Benson LM, Keshavarzian A. An initial report of sleep disturbance in inactive inflammatory bowel disease. J Clin Sleep Med. 2006 Oct 15;2(4):409-16.
PubMed 17557469Ali T, Madhoun MF, Orr WC, Rubin DT. Assessment of the relationship between quality of sleep and disease activity in inflammatory bowel disease patients. Inflamm Bowel Dis. 2013 Oct;19(11):2440-3. doi: 10.1097/MIB.0b013e3182a0ea54.
PubMed 23945186Singh 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.
Swanson GR, Gorenz A, Shaikh M, Desai V, Kaminsky T, Van Den Berg J, Murphy T, Raeisi S, Fogg L, Vitaterna MH, Forsyth C, Turek F, Burgess HJ, Keshavarzian A. Night workers with circadian misalignment are susceptible to alcohol-induced intestinal hyperpermeability with social drinking. Am J Physiol Gastrointest Liver Physiol. 2016 Jul 1;311(1):G192-201. doi: 10.1152/ajpgi.00087.2016. Epub 2016 May 19.
PubMed 27198191Summa KC, Voigt RM, Forsyth CB, Shaikh M, Cavanaugh K, Tang Y, Vitaterna MH, Song S, Turek FW, Keshavarzian A. Disruption of the Circadian Clock in Mice Increases Intestinal Permeability and Promotes Alcohol-Induced Hepatic Pathology and Inflammation. PLoS One. 2013 Jun 18;8(6):e67102. doi: 10.1371/journal.pone.0067102. Print 2013.
PubMed 23825629Beaugerie L, Sokol H. Clinical, serological and genetic predictors of inflammatory bowel disease course. World J Gastroenterol. 2012 Aug 7;18(29):3806-13. doi: 10.3748/wjg.v18.i29.3806.
PubMed 22876031Grimstad T, Norheim KB, Isaksen K, Leitao K, Hetta AK, Carlsen A, Karlsen LN, Skoie IM, Goransson L, Harboe E, Aabakken L, Omdal R. Fatigue in Newly Diagnosed Inflammatory Bowel Disease. J Crohns Colitis. 2015 Sep;9(9):725-30. doi: 10.1093/ecco-jcc/jjv091. Epub 2015 May 19.
PubMed 25994356Ranjbaran Z, Keefer L, Farhadi A, Stepanski E, Sedghi S, Keshavarzian A. Impact of sleep disturbances in inflammatory bowel disease. J Gastroenterol Hepatol. 2007 Nov;22(11):1748-53. doi: 10.1111/j.1440-1746.2006.04820.x.
PubMed 17914945Shearman LP, Sriram S, Weaver DR, Maywood ES, Chaves I, Zheng B, Kume K, Lee CC, van der Horst GT, Hastings MH, Reppert SM. Interacting molecular loops in the mammalian circadian clock. Science. 2000 May 12;288(5468):1013-9. doi: 10.1126/science.288.5468.1013.
PubMed 10807566Nakahata Y, Yoshida M, Takano A, Soma H, Yamamoto T, Yasuda A, Nakatsu T, Takumi T. A direct repeat of E-box-like elements is required for cell-autonomous circadian rhythm of clock genes. BMC Mol Biol. 2008 Jan 4;9:1. doi: 10.1186/1471-2199-9-1.
PubMed 18177499Ramsey KM, Yoshino J, Brace CS, Abrassart D, Kobayashi Y, Marcheva B, Hong HK, Chong JL, Buhr ED, Lee C, Takahashi JS, Imai S, Bass J. Circadian clock feedback cycle through NAMPT-mediated NAD+ biosynthesis. Science. 2009 May 1;324(5927):651-4. doi: 10.1126/science.1171641. Epub 2009 Mar 19.
PubMed 19299583Laposky AD, Bradley MA, Williams DL, Bass J, Turek FW. Sleep-wake regulation is altered in leptin-resistant (db/db) genetically obese and diabetic mice. Am J Physiol Regul Integr Comp Physiol. 2008 Dec;295(6):R2059-66. doi: 10.1152/ajpregu.00026.2008. Epub 2008 Oct 8.
PubMed 18843095Hoogerwerf WA, Hellmich HL, Cornelissen G, Halberg F, Shahinian VB, Bostwick J, Savidge TC, Cassone VM. Clock gene expression in the murine gastrointestinal tract: endogenous rhythmicity and effects of a feeding regimen. Gastroenterology. 2007 Oct;133(4):1250-60. doi: 10.1053/j.gastro.2007.07.009. Epub 2007 Jul 12.
PubMed 17919497Bozek K, Relogio A, Kielbasa SM, Heine M, Dame C, Kramer A, Herzel H. Regulation of clock-controlled genes in mammals. PLoS One. 2009;4(3):e4882. doi: 10.1371/journal.pone.0004882. Epub 2009 Mar 16.
PubMed 19287494
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Misalignment as a Disease Risk Factor in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04637399
- Acronym / sponsor ID
- 16080305
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The long term goal of this Research proposal is to establish that circadian misalignment is a factor for disease flare in inflammatory bowel disease (IBD). In order to achieve this goal this project will focus on two aspects that are critical to address in the management of IBD - disease course and subclinical inflammation. One of the most challenging aspects of IBD medical care is that IBD has a very heterogeneous disease course. Some patients will quickly progress to surgery despite aggressive medical therapy while others have no disease flares on any medications. In order to address these factors, the investigator will access multiple factors about each IBD patient to determine what their previous disease course has been (history), known factors of their disease that are associated with disease course (location, age of diagnosis, etc), and markers of subclinical inflammation that are established predictors of disease flare. Our overall hypothesis is that circadian misalignment is an important factor in the disease course in IBD. To test this hypothesis, the investigator will conduct a series of experiments in humans to elucidate the role of circadian rhythms in IBD. In Aim 1, the investigator will test the hypothesis that circadian misalignment is present in IBD with an aggressive disease course by analyzing circadian rhythms by wrist actigraphy, urinary melatonin, and chronotype questionnaires. In Aim 2, the investigator will assess markers of subclinical inflammation in the same subjects from Aim1, and analyze established predictors of disease flare such as CRP, intestinal permeability, fecal calprotectin, and mucosal inflammation markers. The goal of this research proposal is to identify whether circadian misalignment is a factor in disease course in IBD. It is not to determine if IBD patients have increased circadian misalignment compared to healthy controls, therefore healthy controls are not used as a comparison group. However, Dr. Burgess and Dr. Levi's labs do have a large historical cohort of over 100 healthy controls that have completed wrist actigraphy measurements and chronotype questionnaires that can be used as a comparison if our hypothesis is proven incorrect.
Experimental Design: Subjects with biopsy proven IBD (N=68) will be recruited, 24 CD (Crohn's Disease) and 24 UC (Ulcerative Colitis). All subjects will be between 18-70 years old. Subjects will be recruited from the Rush University GI Clinic. All subjects will complete questionnaires including IBD demographic history, an IBD quality of life, food timing, sleep questionnaires - PROMIS and RUSATED, and chronotype questionnaires - Owl and Lark and Munich. Each subject will be accessed by the PI for exclusion criteria including: 1) Active IBD (HBI ≥ 5 or Modified HBI ≥5); 2) Major depression (score ≥ 15 or any endorsement of suicidal intent on the Beck Depression; 3) Sleep apnea (score high risk ≥ 2 or more categories on the Berlin Questionnaire)(43); 4) Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale(44)); 5) Regular use of medications that affect intestinal permeability, and/or endogenous melatonin including metoclopramide, NSAIDs, beta blocker, psychotropic medication, hypnotics and exogenous melatonin products during 4 weeks prior to the study; 6) People who have worked night shifts or crossed more than 2 time zones in the previous month; 7) Any major organ disease - renal impairment (creatinine>1.2 mg/dL - previous EMR labs must be within the past 12 months), diabetes (Hgb-A1c > 6.5% - no history of any form of diabetes); liver disease (LFTs > 1.5x nl - previous EMR labs must be within the past 12 months), or significant cardiac problems; 8) Inability to sign an informed consent.
Subjects that meet these inclusion/exclusion criteria will be assessed by the PI, who will perform a physical exam, take a history, and review prior medical testing. Subjects will matched 1:1 during recruitment so N=12 in both CD and UC with aggressive disease and N=12 in both CD and UC with nonaggressive disease (See Experimental Design). All subjects will then have their sleep patterns recorded by wrist actigraphy (30 sec epochs, Actiwatch Spectrum, Phillips Inc.) for 14 days (±3 days). Wrist actigraphy is a reliable standard means of assessing sleep-wake activity,(45) and will be used to calculate circadian rhythm by dichotomy index and r24. During the 14days (±3 days) subjects will also keep a detailed consensus sleep diary which is a standardized prospective sleep measure.(46) At the end of the 14 days (±3 days), and a day prior to their visit, all subjects will complete an online self-administered 24 hour food recall (ASA24) and 24 h urine collection for urinary melatonin which is also a marker of central circadian rhythm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis | – | –Participants diagnoses with Ulcerative Colitis. |
| Crohn's Disease | – | –Participants diagnosed with Crohn's Disease. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with Ulcerative Colitis or Crohn's Disease.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Harvey Bradshaw Activity Index
Time frame: 1 Day
Disease Activity: Score 0-4
Beck's Depression Index
Time frame: Past Two Weeks from Date of Visit
Score: 0-14
International Restless Leg Syndrome Scale
Time frame: Past Week from Date of Visit
Score 0-14
Berlin OSA Questionnaire
Time frame: Past 3 Months
Meet 0-1 Category
Short Inflammatory Bowel Disease Questionnaire
Time frame: Past Two Weeks from Date of Visit
Score: 1-7
Munich Chronotype Questionnaire
Time frame: Past 3 Months
Typical Sleep and Wake Habits
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
ActiWatch
Time frame: 14 Day Period
Sleep-Wake Activity Wrist Monitor
Food Timing Questionnaire
Time frame: 14 Day Period
Food and Sleep Habit Diary
Sleep Diary
Time frame: 14 Day Period
Sleep Record
3 secondary outcomes
Urine Samples
Time frame: 1 Day
C-Reactive Protein
Time frame: 10 Weeks +/- 3 Days
Left Sided Colon Tissue Samples
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 18854185Kappelman MD, Rifas-Shiman SL, Porter CQ, Ollendorf DA, Sandler RS, Galanko JA, Finkelstein JA. Direct health care costs of Crohn's disease and ulcerative colitis in US children and adults. Gastroenterology. 2008 Dec;135(6):1907-13. doi: 10.1053/j.gastro.2008.09.012. Epub 2008 Sep 17.
- Background: PubMed 17557469Keefer L, Stepanski EJ, Ranjbaran Z, Benson LM, Keshavarzian A. An initial report of sleep disturbance in inactive inflammatory bowel disease. J Clin Sleep Med. 2006 Oct 15;2(4):409-16.
- Background: PubMed 23945186Ali T, Madhoun MF, Orr WC, Rubin DT. Assessment of the relationship between quality of sleep and disease activity in inflammatory bowel disease patients. Inflamm Bowel Dis. 2013 Oct;19(11):2440-3. doi: 10.1097/MIB.0b013e3182a0ea54.
- BackgroundSingh 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.
- Background: PubMed 27198191Swanson GR, Gorenz A, Shaikh M, Desai V, Kaminsky T, Van Den Berg J, Murphy T, Raeisi S, Fogg L, Vitaterna MH, Forsyth C, Turek F, Burgess HJ, Keshavarzian A. Night workers with circadian misalignment are susceptible to alcohol-induced intestinal hyperpermeability with social drinking. Am J Physiol Gastrointest Liver Physiol. 2016 Jul 1;311(1):G192-201. doi: 10.1152/ajpgi.00087.2016. Epub 2016 May 19.
- Background: PubMed 23825629Summa KC, Voigt RM, Forsyth CB, Shaikh M, Cavanaugh K, Tang Y, Vitaterna MH, Song S, Turek FW, Keshavarzian A. Disruption of the Circadian Clock in Mice Increases Intestinal Permeability and Promotes Alcohol-Induced Hepatic Pathology and Inflammation. PLoS One. 2013 Jun 18;8(6):e67102. doi: 10.1371/journal.pone.0067102. Print 2013.
- Background: PubMed 22876031Beaugerie L, Sokol H. Clinical, serological and genetic predictors of inflammatory bowel disease course. World J Gastroenterol. 2012 Aug 7;18(29):3806-13. doi: 10.3748/wjg.v18.i29.3806.
- Background: PubMed 25994356Grimstad T, Norheim KB, Isaksen K, Leitao K, Hetta AK, Carlsen A, Karlsen LN, Skoie IM, Goransson L, Harboe E, Aabakken L, Omdal R. Fatigue in Newly Diagnosed Inflammatory Bowel Disease. J Crohns Colitis. 2015 Sep;9(9):725-30. doi: 10.1093/ecco-jcc/jjv091. Epub 2015 May 19.
- Background: PubMed 17914945Ranjbaran Z, Keefer L, Farhadi A, Stepanski E, Sedghi S, Keshavarzian A. Impact of sleep disturbances in inflammatory bowel disease. J Gastroenterol Hepatol. 2007 Nov;22(11):1748-53. doi: 10.1111/j.1440-1746.2006.04820.x.
- Background: PubMed 10807566Shearman LP, Sriram S, Weaver DR, Maywood ES, Chaves I, Zheng B, Kume K, Lee CC, van der Horst GT, Hastings MH, Reppert SM. Interacting molecular loops in the mammalian circadian clock. Science. 2000 May 12;288(5468):1013-9. doi: 10.1126/science.288.5468.1013.
- Background: PubMed 18177499Nakahata Y, Yoshida M, Takano A, Soma H, Yamamoto T, Yasuda A, Nakatsu T, Takumi T. A direct repeat of E-box-like elements is required for cell-autonomous circadian rhythm of clock genes. BMC Mol Biol. 2008 Jan 4;9:1. doi: 10.1186/1471-2199-9-1.
- Background: PubMed 19299583Ramsey KM, Yoshino J, Brace CS, Abrassart D, Kobayashi Y, Marcheva B, Hong HK, Chong JL, Buhr ED, Lee C, Takahashi JS, Imai S, Bass J. Circadian clock feedback cycle through NAMPT-mediated NAD+ biosynthesis. Science. 2009 May 1;324(5927):651-4. doi: 10.1126/science.1171641. Epub 2009 Mar 19.
- Randomised clinical trial: Deep remission in biologic and immunomodulator naïve patients with crohn's disease - a SONIC post hoc analysis. - PubMed - NCBI \[homepage on the Internet\]. \[cited 6/9/2016\].Link provided by the sponsor.
Related trials for Inflammatory Bowel Diseases
Active, not recruitingObservational study
A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis
Colitis, Ulcerative
RecruitingObservational study
Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease
Periodontal Diseases, IBD
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
RecruitingPhase 1/2
Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis
Ulcerative Colitis (UC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garth Swanson, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harvey Bradshaw Activity Index (time frame: 1 Day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04637399, which also lists 46 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.