Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis

Study Purpose

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 3, at the completion of first arm (Condition 1), and 3) month 6, after completion of the second arm (Condition 2).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. M/F, 18-65 years of age. 2. Ulcerative Colitis with Inactive Disease (Mayo Score ≤ 2; partial Mayo Score ≤ 1 with endoscopic score 0-1) 3. Subclinical inflammation (stool calprotectin >50 or CRP > 8 mg/L) 4. Stable medications with no disease flares for the > 3 months. 5. Normal psychological evaluation and negative drug screen (See Below)

Exclusion Criteria:

1. Active UC at enrollment (Mayo > 2 and/or sigmoidoscopy score of 2 or 3) 2. Prior ostomy or subtotal colectomy. 3. Recent prednisone or antibiotic use in last 12 weeks. 4. Use of biologic or immunomodulatory medications (i.e. Infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.) 5. Major Depression identified as Beck Depression Inventory (score ≥14) 6. Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale) 7. Sleep apnea (score high risk ≥ 2 or more categories on the Berlin Questionnaire) 8. Clinically significant diabetes (Hgb-A1c>7) 9. Regular use of medications that affect intestinal permeability, intestinal motility and/or endogenous melatonin including metoclopramide, NSAIDs, beta blocker, psychotropic medication, hypnotics and exogenous melatonin products during 4 weeks prior to the study. 10. Atypical American diet (FFQ 5-15 g fiber per day) 11. Clinically significant cardiac, renal (creatinine > twice normal) or liver disease. 12. Alcohol use disorder (AUDIT>8) 13. Chronic use of illicit drugs. 14. Shift Work. 15. Children under 6 months. 16. Inability to sign an informed consent

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05213234
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rush University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

Other: Morning Medication Administration

Subjects are directed to take their medication between 06:00 and 10:00.

Other: Night Medication Administration

Subjects are directed to take their medication between 18:00 and 22:00.

Interventions

Behavioral: - Chronotherapy

Chronotherapy is a behavioral intervention that has the intended effect of maximizing therapeutic benefit of a drug by coordinating intake times and biological rhythms.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rush University Medical Center, Chicago, Illinois

Status

Recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60068

Site Contact

Alexander Yerkan, B.S.

alexander_m_yerkan@rush.edu

847-769-8298