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Chronotherapy in Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT04304950
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Garth Swanson, MD, Rush University Medical Center

Study Description
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Brief Summary:
This study aims to determine if there is any difference in the efficacy of Inflammatory Bowel Disease (IBD) medication and disease outcomes when taken in the morning or in the evening. The IBD medications being observed are azathioprine and 6-mercaptopurine. The study team believes that there may be a benefit to taking the medication at a certain time of day. To test this theory the study asks participants who are already taking either azathioprine or 6-mercaptopurine for IBD to take the medication consistently at either the morning or in the evening based on when they currently take their medication. Participation is up to 10 weeks +/- 3 days. There will be 2 study visits where the participant will be asked to fill in questionnaires related to their IBD symptoms, their sleep habits, sleep quality, and general health information followed by a blood draw.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Drug: Evening Group Drug: Morning Group Phase 4

Detailed Description:

The objective of this study is to determine whether the timing of drug administration to treat inflammatory bowel disease (IBD) has an effect on patient outcomes. Primary objective: Determine whether there is a difference in outcomes seen when patients are assigned to take their prescribed immunomodulator (IM) - either Azathioprine or 6-Mercaptopurine - at either a morning delivery time or evening delivery time.

The Investigator hypothesize that administration time of immunomodulators (IMs) during the day can affect the clinical outcomes in IBD patients.

Specific Aims Include:

  • Determine whether morning vs. evening dosing of patients' prescribed IMs (either Azathioprine or 6-Mercaptopurine) could affect the subclinical markers of inflammation related to disease.
  • Determine whether morning vs. evening dosing of patients' prescribed IMs (either Azathioprine or 6-Mercaptopurine) could affect endoscopic outcomes.
  • Determine whether morning vs. evening dosing of IMs affect their biochemical side effects, as is routinely monitored as part of the patients' clinical care.
  • Determine if outcomes correlate with patients' chronotype, as determined by standard questionnaires (the Owl and Lark Questionnaire and the Munich Chronotype Questionnaire).

Description of Procedures: After signing the informed consent form, subjects will be asked to answer the Inflammatory Bowel Disease Questionnaire (IBDQ), the Munich Chronotype Questionnaire (MCTQ), the Owl and Lark Questionnaire, the Harvey Bradshaw questionnaire, the RU SATED questionnaire, and a demographics survey. All six of these questionnaires are included with this IRB. Next, patients will be assigned a time (morning or evening) to self administer their prescribed medication for 10 weeks. Patients who currently take their medication in the morning will be asked to switch to an evening delivery and patients who currently take their medication at night will be asked to switch to a morning delivery. The group assigned to morning delivery time will be told to take their medication between 6am and 11am. The group assigned to evening delivery time will be told to take their medication between 6pm and 11pm. Lastly, patients will be asked to give a blood sample to test for complete blood count (CBC), comprehensive metabolic panel (CMP), C-reactive protein (CRP), methylmercaptopurine (6-MMP), and thioguanine nucleotides (6-TG). Plasma and serum isolated from the blood sample will be temporarily stored to measure inflammatory cytokines after every 20 subjects complete the study.

Within a 6-10 week window, as part of their clinical care, subjects will come in to assess their clinical status while undergoing biochemical monitoring every 2-4 weeks. Data from their endoscopic examination, if done, will also be collected.

After 10 weeks, the subjects will be asked to complete the IBDQ and Harvey Bradshaw questionnaire. In addition, a blood sample will be obtained to measure the same metabolite levels and other biochemical indications of disease as stated above. Again, plasma and serum will be isolated from the blood sample and stored.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to one of two groups: Evening Time or Morning Time. Participants are used as their own control. The evening time group will take their medication in the evening and the morning time group will take the medication in the morning.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chronotherapy in Inflammatory Bowel Disease
Actual Study Start Date : April 25, 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Ulcerative Colitis: Azathioprine
Participants with Ulcerative Colitis taking Azathioprine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.
 Drug: Evening Group
Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm.

Drug: Morning Group
Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am.
Experimental: Ulcerative Colitis: 6-Mercaptopurine
Participants with Ulcerative Colitis taking 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.
 Drug: Evening Group
Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm.

Drug: Morning Group
Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am.
Experimental: Crohn's Disease: Azathiopurine
Participants with Crohn's Disease taking Azathioprine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.
 Drug: Evening Group
Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm.

Drug: Morning Group
Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am.
Experimental: Crohn's Disease: 6-Mercaptopurine
Participants with Crohn's Disease taking 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.
 Drug: Evening Group
Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm.

Drug: Morning Group
Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am.


Outcome Measures
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Primary Outcome Measures :
  1. Thioguanine levels in blood [ Time Frame: 10 weeks post baseline visit. ]
    This is to examine if the intervention results in a greater level of thioguanine in the participants. If so, the participants are expected to have less symptom severity. Comparing baseline taken at visit one to visit two levels 10 weeks after intervention start.

  2. Harvey Bradshaw Activity Index [ Time Frame: 10 weeks post baseline visit. ]
    Disease Activity: >16 severe disease, 8-16 moderate disease, 5-7 mild disease, <5 remission

  3. Short Inflammatory Bowel Disease Questionnaire [ Time Frame: 10 weeks post baseline visit. ]
    Quality of Life Measure Score:1-7 (The higher the number the greater the quality of life)

  4. 6-Methylmercaptopurine levels in blood [ Time Frame: 10 weeks post baseline visit. ]
    This is to examine if the intervention results in a lower level of 6-Methylmercaptopurine in the participants. If so, the participants are expected to have less symptom severity. Comparing baseline taken at visit one to visit two levels 10 weeks after intervention start.


Secondary Outcome Measures :
  1. Owl and Lark Questionnaire [ Time Frame: 10 weeks post baseline visit. ]
    Measure: Morning Type (Score 70-86), Moderate Morning Type (Score 59-69), Neither Type (42-58), Moderate Evening Type (Score 31-41), Evening Type (Score 16-30).

  2. Munich Chronotype Questionnaire [ Time Frame: 10 weeks post baseline visit. ]
    0-6 on some of the items in the original questionnaire (extreme early to extreme late chronotype).

  3. RU SATED Questionnaire [ Time Frame: 10 weeks post baseline visit. ]
    Sleep Quality Score: 0-12 (0 = Poor Sleep Health, 12 = Good Sleep Health)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Above the ages of 18
  • Diagnosis of Crohn's Disease or Ulcerative Colitis
  • Currently taking azathioprine or 6-mercaptopurine
  • Willing to sign study consent form

Exclusion Criteria:

  • Vulnerable population (pregnant, prisoner, non-English speaking or cognitively impaired)
  • Breastfeeding subject
  • Have a history of complications related to immunomodulatory therapy
  • Participating in other research studies involving research interventions
  • Treated with dual corticosteroid and immunomodulatory therapy
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04304950


Contacts
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Contact: Garth Swanson, MD 312-942-5861

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Garth Swanson, MD    312-942-5861      
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Garth Swanson, MD Rush University Medical Center
  Study Documents (Full-Text)

Documents provided by Garth Swanson, MD, Rush University Medical Center:
Informed Consent Form  [PDF] March 10, 2019

More Information
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Additional Information:

Publications:

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Responsible Party: Garth Swanson, MD, Associate Professor of Medicine Director, Rush Center of Crohn's & Colitis Director, Clinical Chronobiology Center, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT04304950    
Other Study ID Numbers: 16040505
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis