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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The hypothesis of this study is that appropriate time of day of administration of oral, once daily 5-ASA therapy in alignment with the host circadian rhythms will improve subclinical inflammation and microbial structure/function and increase mucosal 5-ASA levels.
All subjects will be randomized to once daily 5-ASA medications at two different times of the day: between 06:00 - 10:00 h or 18:00 - 22:00 h. Three disease assessments will performed at: 1) enrollment just before randomization; 2) month 1, at the completion of first arm (Condition 1), and 3) month 3, after completion of the second arm (Condition 2). During these study time points, participants will be asked to complete questionnaires, track their 5-ASA medication usage, provide a stool sample, blood draw, urine test, collect saliva, wear a watch to measure sleep patterns, and complete a flexible sigmoidoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morning Medication Administration | Other | Subjects are directed to take their medication between 06:00 and 10:00. |
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| Night Medication Administration | Other | Subjects are directed to take their medication between 18:00 and 22:00. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chronotherapy | Behavioral | Chronotherapy is a behavioral intervention that has the intended effect of maximizing therapeutic benefit of a drug by coordinating intake times and biological rhythms. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stool Calprotectin from Baseline to Morning Medication Administration to Night Medication Administration | ELISA | 10 minute stool collection at Baseline, 10 minute stool collection at Morning Medication Administration, and 10 minute stool collection at Night Medication Administration |
| Change in Mucosal 5-ASA Concentration from Baseline to Morning Medication Administration to Night Medication Administration | HPLC of tissue samples taken during flexible sigmoidoscopy at Baseline, Morning Medication Administration and Night Medication Administration | 30 minute flexible sigmoidoscopy at Baseline, 30 minute flexible sigmoidoscopy at Morning Medication Administration, and 30 minute flexible sigmoidoscopy at Night Medication Administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intestinal Permeability from Baseline to Morning Medication Administration to Night Medication Administration | Intestinal permeability is assessed through spectrophotometric measurements of sucralose, sucrose, maltose and lactulose concentrations in urine following ingestion of a sugar cocktail. | 24 hour urine collection at baseline, 24 hour urine collection at Morning Medication Administration, and 24 hour urine collection at Night Medication Administration |
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Inclusion Criteria: Study will include individuals that are;
Exclusion Criteria: Study will not include individuals that are;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60068 | United States | ||
| The Medical University of South Carolina |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 29, 2024 | Mar 23, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019454 | Chronotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Change in Serum Cytokines from Baseline to Morning Medication Administration to Night Medication Administration | LBP, LPS, zonulin, and sCD14 | Single blood draw at baseline, single blood draw at Morning Medication Administration, and single blood draw at Night Medication Administration |
| Change in Mayo Score from Baseline to Morning Medication Administration to Night Medication Administration | Mayo Score | 5 minute questionnaire at Baseline, 5 minute questionnaire at Morning Medication Administration, 5 minute questionnaire at Night Medication Administration |
| Change in Circadian Rhythms from Baseline to Morning Medication Administration to Night Medication Administration | Wrist Actigraphy | Wrist Actigraphy Watch worn for two weeks at Baseline, two weeks at Morning Medication Administration, and two weeks at night medication administration |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |