Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis

NCT05213234 | Active Not Recruiting

• 1 other identifier: 20052807
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Change in Intestinal Permeability from Baseline to Morning Medication Administration to Night Medication Administration

  24 hour urine collection at baseline, 24 hour urine collection at Morning Medication Administration, and 24 hour urine collection at Night Medication Administration

• Change in Serum Cytokines from Baseline to Morning Medication Administration to Night Medication Administration

  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

  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 Watch worn for two weeks at Baseline, two weeks at Morning Medication Administration, and two weeks at night medication administration

Study Arms (2)

Morning Medication Administration

OTHER

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

Behavioral: Chronotherapy

Night Medication Administration

OTHER

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

Behavioral: Chronotherapy

Interventions

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.

Morning Medication Administration; Night Medication Administration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Rush University Medical Center: lead

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60068, United States

Location

The Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Chronotherapy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Section of Gastroenterology

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 28, 2022
• Study Start: July 9, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)