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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
No Placebo-Only Group
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 belowSelect...
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:Select...
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.
Select...
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.
Select...
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
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
249,192 Total Patients Enrolled
3 Trials studying Colitis
131 Patients Enrolled for Colitis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,449 Previous Clinical Trials
4,332,407 Total Patients Enrolled
16 Trials studying Colitis
5,311 Patients Enrolled for Colitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken drugs affecting my gut or NSAIDs in the last 4 weeks.I have had surgery to remove part of my colon or to create an opening for waste to leave my body.I am between 18 and 65 years old.I do not have serious heart, kidney, or liver disease.I am unable to give my consent for treatment.My diabetes is significant with Hgb-A1c over 7.My ulcerative colitis is currently inactive.My child is under 6 months old.My ulcerative colitis is currently active.My restless leg syndrome is severe.I am currently taking medications that affect my immune system.My medications have been stable and I've had no worsening of my condition for over 3 months.I have not taken prednisone or antibiotics in the last 12 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Morning Medication Administration
- Group 2: Night Medication Administration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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