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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)
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
Study 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.Check my eligibility
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.See study design
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.
Select...
My ulcerative colitis is currently inactive.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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
422 Previous Clinical Trials
163,441 Total Patients Enrolled
4 Trials studying Ulcerative Colitis
204 Patients Enrolled for Ulcerative Colitis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,315,435 Total Patients Enrolled
13 Trials studying Ulcerative Colitis
2,092 Patients Enrolled for Ulcerative 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who has the eligiblity to take part in this trial?
"To qualify for this trial, potential participants must suffer from ulcer and have a chronological age between 18 to 65. Currently, 60 persons are being recruited into the clinical study."
Answered by AI
What is the current enrollment capacity for this medical experiment?
"Affirmative. Information housed on clinicaltrials.gov reveals that, since its posting on July 9th 2021, this medical trial has been actively recruiting patients with a target of 60 individuals from 1 site."
Answered by AI
Is this research project open to new participants at the present time?
"Per clinicaltrials.gov, this research is actively enrolling volunteers. The trial was initially published on July 9th 2021 and underwent a revision as recently as February 11th 2022."
Answered by AI
Is this research catering to elderly individuals?
"Patients between 18 and 65 are eligible to join this trial. Additionally, there is a pool of 70 studies targeting minors, as well as 347 trials for the elderly population."
Answered by AI
What research objectives are driving this investigation?
"The primary objective of this trial, involving 30 minute flexible sigmoidoscopies at Baseline, Morning Medication Administration and Night Medication Administration time frames is to evaluate the variation in stool calprotectin levels. Secondary aims include tracking changes in serum cytokines (LBP, LPS, zonulin & sCD14), intestinal permeability (through spectrophotometric measurements of sucralose/sucrose/maltose/lactulose concentrations) and circadian rhythms (using wrist actigraphy)."
Answered by AI
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