Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    60
  • sponsor
    Rush University Medical Center
Updated on 22 March 2022

Summary

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).

Details
Condition Ulcerative Colitis
Treatment Chronotherapy
Clinical Study IdentifierNCT05213234
SponsorRush University Medical Center
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Active UC at enrollment (Mayo > 2 and/or sigmoidoscopy score of 2 or 3)
Prior ostomy or subtotal colectomy
Recent prednisone or antibiotic use in last 12 weeks
Use of biologic or immunomodulatory medications (i.e. Infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.)
Major Depression identified as Beck Depression Inventory (score ≥14)
Restless leg syndrome (score ≥ 15 on the IRLS Study Group Rating Scale)
Sleep apnea (score high risk ≥ 2 or more categories on the Berlin Questionnaire)
Clinically significant diabetes (Hgb-A1c>7)
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
Atypical American diet (FFQ 5-15 g fiber per day)
Clinically significant cardiac, renal (creatinine > twice normal) or liver disease
Alcohol use disorder (AUDIT>8)
Chronic use of illicit drugs
Shift Work
Children under 6 months
Inability to sign an informed consent
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