Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT05213234
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2021-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019454', 'term': 'Chronotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2021-12-09', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Stool Calprotectin from Baseline to Morning Medication Administration to Night Medication Administration', 'timeFrame': '10 minute stool collection at Baseline, 10 minute stool collection at Morning Medication Administration, and 10 minute stool collection at Night Medication Administration', 'description': 'ELISA'}, {'measure': 'Change in Mucosal 5-ASA Concentration from Baseline to Morning Medication Administration to Night Medication Administration', 'timeFrame': '30 minute flexible sigmoidoscopy at Baseline, 30 minute flexible sigmoidoscopy at Morning Medication Administration, and 30 minute flexible sigmoidoscopy at Night Medication Administration', 'description': 'HPLC of tissue samples taken during flexible sigmoidoscopy at Baseline, Morning Medication Administration and Night Medication Administration'}], 'secondaryOutcomes': [{'measure': 'Change in Intestinal Permeability from Baseline to Morning Medication Administration to Night Medication Administration', 'timeFrame': '24 hour urine collection at baseline, 24 hour urine collection at Morning Medication Administration, and 24 hour urine collection at Night Medication Administration', 'description': 'Intestinal permeability is assessed through spectrophotometric measurements of sucralose, sucrose, maltose and lactulose concentrations in urine following ingestion of a sugar cocktail.'}, {'measure': 'Change in Serum Cytokines from Baseline to Morning Medication Administration to Night Medication Administration', 'timeFrame': 'Single blood draw at baseline, single blood draw at Morning Medication Administration, and single blood draw at Night Medication Administration', 'description': 'LBP, LPS, zonulin, and sCD14'}, {'measure': 'Change in Mayo Score from Baseline to Morning Medication Administration to Night Medication Administration', 'timeFrame': '5 minute questionnaire at Baseline, 5 minute questionnaire at Morning Medication Administration, 5 minute questionnaire at Night Medication Administration', 'description': 'Mayo Score'}, {'measure': 'Change in Circadian Rhythms from Baseline to Morning Medication Administration to Night Medication Administration', 'timeFrame': 'Wrist Actigraphy Watch worn for two weeks at Baseline, two weeks at Morning Medication Administration, and two weeks at night medication administration', 'description': 'Wrist Actigraphy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': '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.\n\nAll 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 3, at the completion of first arm (Condition 1), and 3) month 6, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Study will include individuals that are;\n\n1. M/F, 18-65 years of age\n2. Ulcerative Colitis with Inactive Disease (Mayo Score ≤ 2; partial Mayo Score ≤ 1 with endoscopic score 0-1)\n3. Subclinical inflammation stool calprotectin \\> 50 or CRP \\> mg/L above the upper limit of normal or PROMIS Fatigue Score ≥ 50)\n4. Stable medications with no disease flares for the \\> 3 months,\n\nExclusion Criteria: Study will not include individuals that are;\n\n1. Active UC at enrollment (Mayo \\> 2 and/or sigmoidoscopy score of 2 or 3)\n2. Regular use of suppositories or enemas within the last 3 months ORA: 20052807-IRB01 Date IRB Approved: 11/6/2023 Amendment Date: 4/7/2024 Protocol Version Date: 4/4/2024 7\n3. Use of biologics or immunomodulatory medications ( i.e. infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.)\n4. Prior ostomy or subtotal colectomy\n5. Recent prednisone or antibiotic use in last 12 weeks\n6. Major Depression identified as Beck Depression Inventory (score ≥21)\n7. Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale)\n8. Sleep apnea (score high risk ≥ 2 or more categories on the Berlin Questionnaire)\n9. Clinically significant diabetes (Hgb-A1c\\>7)\n10. Regular use of medications that affect intestinal permeability, intestinal motility and/or NSAIDs 4 weeks prior to the study\n11. Clinically significant cardiac, renal (creatinine \\> twice normal) or liver disease\n12. Alcohol use disorder (AUDIT\\>8)\n13. Chronic use of illicit drugs\n14. Shift Work\n15. Inability to sign an informed consen'}, 'identificationModule': {'nctId': 'NCT05213234', 'briefTitle': 'Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis: A Randomized Crossover Trial', 'orgStudyIdInfo': {'id': '20052807'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Morning Medication Administration', 'description': 'Subjects are directed to take their medication between 06:00 and 10:00.', 'interventionNames': ['Behavioral: Chronotherapy']}, {'type': 'OTHER', 'label': 'Night Medication Administration', 'description': 'Subjects are directed to take their medication between 18:00 and 22:00.', 'interventionNames': ['Behavioral: Chronotherapy']}], 'interventions': [{'name': 'Chronotherapy', 'type': 'BEHAVIORAL', 'description': 'Chronotherapy is a behavioral intervention that has the intended effect of maximizing therapeutic benefit of a drug by coordinating intake times and biological rhythms.', 'armGroupLabels': ['Morning Medication Administration', 'Night Medication Administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60068', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'The Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of the Section of Gastroenterology', 'investigatorFullName': 'Ali Keshavarzian', 'investigatorAffiliation': 'Rush University Medical Center'}}}}