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NCT05213234 · ClinicalTrials.gov registry record · NA
Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis
A NA study of Ulcerative Colitis, sponsored by Rush University Medical Center.
- Active
- Registry status
- NA
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT05213234: Active NA study of Ulcerative Colitis, sponsored by Rush University Medical Center.
NCT05213234 is a NA study of Ulcerative Colitis that is active but no longer recruiting, run by Rush University Medical Center. The registered enrollment target is 32 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05213234, a NA study of Ulcerative Colitis, is active but no longer recruiting, sponsored by Rush University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study 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 3, at the completion of first arm (Condition 1), and 3) month 6, 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.
Primary Outcome
ELISA
Conditions Studied
Interventions
- BEHAVIORAL Chronotherapy
Study Locations (2)
Illinois
- Rush University Medical Center - Chicago
South Carolina
- The Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2021-07-09 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
What the registry record for NCT05213234 still lists
NCT05213234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Chronotherapy is the first listed.
NCT05213234 reports a single indexed study location in Illinois, South Carolina.
Frequently Asked Questions
What is clinical trial NCT05213234 about?
NCT05213234 is a clinical study titled "Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis". 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 ...
What is the current status of trial NCT05213234?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 32 participants. The study started on 2021-07-09. Estimated completion is 2026-03-31.
What conditions does trial NCT05213234 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT05213234?
The interventions under investigation include: Chronotherapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT05213234?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05213234 being conducted?
This trial has 2 study locations across Illinois, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05213234's enrollment target sits among peer trials
32 101st of 122 higher than 22 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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