Ulcerative ColitisNCT05213234
Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis
A study testing Chronotherapy in people with Ulcerative Colitis, run by Rush University Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Chronotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jul 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Medical University of South Carolina
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60068
About this study
Official title: Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis: A Randomized Crossover Trial
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
- Being tested
- Chronotherapy
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChronotherapyBehavioural
Chronotherapy is a behavioral intervention that has the intended effect of maximizing therapeutic benefit of a drug by coordinating intake times and biological rhythms.
| Study group | Role | What they receive |
|---|---|---|
| Morning Medication Administration | Other | Subjects are directed to take their medication between 06:00 and 10:00. Receives: Behavioral: Chronotherapy |
| Night Medication Administration | Other | Subjects are directed to take their medication between 18:00 and 22:00. Receives: Behavioral: Chronotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stool Calprotectin from Baseline to Morning Medication Administration to Night Medication Administration
ELISA
Measured: 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
Measured: 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
Intestinal permeability is assessed through spectrophotometric measurements of sucralose, sucrose, maltose and lactulose concentrations in urine following ingestion of a sugar cocktail.
Measured: 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
LBP, LPS, zonulin, and sCD14
Measured: 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
Mayo Score
Measured: 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
Measured: Wrist Actigraphy Watch worn for two weeks at Baseline, two weeks at Morning Medication Administration, and two weeks at night medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start9 Jul 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Keshavarzian, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213234
- Sponsor's protocol ID
- 20052807
- Status last verified
- Jun 2026
- First submitted
- 9 Dec 2021
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05213234
- Acronym / sponsor ID
- 20052807
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning Medication Administration | Other | Behavioral: ChronotherapySubjects are directed to take their medication between 06:00 and 10:00. |
| Night Medication Administration | Other | Behavioral: ChronotherapySubjects are directed to take their medication between 18:00 and 22:00. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChronotherapyChronotherapy is a behavioral intervention that has the intended effect of maximizing therapeutic benefit of a drug by coordinating intake times and biological rhythms. | Behavioural | Morning Medication Administration, Night Medication Administration |
Primary outcome
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
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
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronotherapy in people with Ulcerative Colitis, run by Rush University Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.