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5-ASA Chronotherapy for Ulcerative Colitis

N/A

Recruiting

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

M/F, 18-65 years of age

Ulcerative Colitis with Inactive Disease (Mayo Score ≤ 2; partial Mayo Score ≤ 1 with endoscopic score 0-1)

Must not have

Regular use of medications that affect intestinal permeability, intestinal motility and/or NSAIDs, products during 4 weeks prior to the study

Prior ostomy or subtotal colectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 minute questionnaire at baseline, 5 minute questionnaire at morning medication administration, 5 minute questionnaire at night medication administration

Awards & highlights

Summary

This trial will test if taking 5-ASA at different times of the day can help improve symptoms for those with inflammatory bowel disease.

Who is the study for?

Adults aged 18-65 with inactive Ulcerative Colitis and signs of subclinical inflammation can join this trial. They must have stable health, no recent flares or use of certain drugs, and a typical American diet. Excluded are those with significant heart, kidney, liver issues, drug abuse history, depression, sleep disorders or who've used specific ulcerative colitis treatments recently.

What is being tested?

The study tests if taking the ulcerative colitis medication 5-ASA at different times (morning vs evening) affects inflammation and gut microbes. Participants will be randomly assigned to take the medicine in one time slot for three months then switch to the other. Assessments include questionnaires and medical tests.

What are the potential side effects?

While not explicitly listed here, common side effects of 5-ASA may include headache, nausea, abdominal pain, indigestion; however individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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My ulcerative colitis is currently inactive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken drugs affecting my gut or NSAIDs in the last 4 weeks.

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I have had surgery to remove part of my colon or to create an opening for waste to leave my body.

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I do not have serious heart, kidney, or liver disease.

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I am unable to give my consent for treatment.

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My diabetes is significant with Hgb-A1c over 7.

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My child is under 6 months old.

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My ulcerative colitis is currently active.

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My restless leg syndrome is severe.

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I am currently taking medications that affect my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 minute stool collection at baseline, 10 minute stool collection at morning medication administration, and 10 minute stool collection at night medication administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 minute stool collection at baseline, 10 minute stool collection at morning medication administration, and 10 minute stool collection at night medication administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minute stool collection at baseline, 10 minute stool collection at morning medication administration, and 10 minute stool collection at night medication administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

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

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

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

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Night Medication AdministrationExperimental Treatment1 Intervention

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

Group II: Morning Medication AdministrationExperimental Treatment1 Intervention

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

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

431 Previous Clinical Trials

158,341 Total Patients Enrolled

4 Trials studying Ulcerative Colitis

183 Patients Enrolled for Ulcerative Colitis

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

2,410 Previous Clinical Trials

4,324,831 Total Patients Enrolled

14 Trials studying Ulcerative Colitis

3,713 Patients Enrolled for Ulcerative Colitis

Media Library

Chronotherapy Clinical Trial Eligibility Overview. Trial Name: NCT05213234 — N/A

Ulcerative Colitis Research Study Groups: Morning Medication Administration, Night Medication Administration

Ulcerative Colitis Clinical Trial 2023: Chronotherapy Highlights & Side Effects. Trial Name: NCT05213234 — N/A

Chronotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05213234 — N/A

~2 spots leftby Oct 2024

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