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NCT Number: NCT05213234

Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Study will include individuals that are;

  • 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 > mg/L above the upper limit of normal or PROMIS Fatigue Score ≥ 50)
  • Stable medications with no disease flares for the > 3 months,

Exclusion criteria

Study will not include individuals that are;

  • Active UC at enrollment (Mayo > 2 and/or sigmoidoscopy score of 2 or 3)
  • Regular use of suppositories or enemas within the last 3 months
  • Use of biologics or immunomodulatory medications ( i.e. infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.)
  • Prior ostomy or subtotal colectomy
  • Recent prednisone or antibiotic use in last 12 weeks
  • Major Depression identified as Beck Depression Inventory (score ≥21)
  • 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 NSAIDs 4 weeks prior to the study
  • Clinically significant cardiac, renal (creatinine > twice normal) or liver disease
  • Alcohol use disorder (AUDIT>8)
  • Chronic use of illicit drugs
  • Shift Work
  • Inability to sign an informed consen

Treatment and study plan

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.

Primary outcomes

  1. Change in Stool Calprotectin from Baseline to Morning Medication Administration to Night Medication Administration

    Time frame: 10 minute stool collection at Baseline, 10 minute stool collection at Morning Medication Administration, and 10 minute stool collection at Night Medication Administration

    ELISA

  2. Change in Mucosal 5-ASA Concentration from Baseline to Morning Medication Administration to Night Medication Administration

    Time frame: 30 minute flexible sigmoidoscopy at Baseline, 30 minute flexible sigmoidoscopy at Morning Medication Administration, and 30 minute flexible sigmoidoscopy at Night Medication Administration

    HPLC of tissue samples taken during flexible sigmoidoscopy at Baseline, Morning Medication Administration and Night Medication Administration

Secondary outcomes

  1. Change in Intestinal Permeability from Baseline to Morning Medication Administration to Night Medication Administration

    Time frame: 24 hour urine collection at baseline, 24 hour urine collection at Morning Medication Administration, and 24 hour urine collection at 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.

  2. Change in Serum Cytokines from Baseline to Morning Medication Administration to Night Medication Administration

    Time frame: Single blood draw at baseline, single blood draw at Morning Medication Administration, and single blood draw at Night Medication Administration

    LBP, LPS, zonulin, and sCD14

  3. Change in Mayo Score from Baseline to Morning Medication Administration to Night Medication Administration

    Time frame: 5 minute questionnaire at Baseline, 5 minute questionnaire at Morning Medication Administration, 5 minute questionnaire at Night Medication Administration

    Mayo Score

  4. Change in Circadian Rhythms from Baseline to Morning Medication Administration to Night Medication Administration

    Time frame: Wrist Actigraphy Watch worn for two weeks at Baseline, two weeks at Morning Medication Administration, and two weeks at night medication administration

    Wrist Actigraphy

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis: A Randomized Crossover Trial

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2022
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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