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NCT04505410 · ClinicalTrials.gov registry record · Phase 3
Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis
A Phase 3 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
NCT04505410: Completed Phase 3 study, sponsored by University of Miami.
NCT04505410 is a Phase 3 study that has completed, run by University of Miami. The registered enrollment target is 32 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04505410, a Phase 3 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether a diet intervention (the Fasting Mimicking diet) will help induce clinical and biochemical response to an advanced therapy in patients with ulcerative colitis. Study period will be 8 weeks during induction of advanced therapies. The primary aims of this study will be clinical response, as determined by the simple clinical colitis activity index (SCCAI). Secondary outcomes will be improvement in fecal calprotectin and C-reactive protein levels.
Primary Outcome
Clinical response will be evaluated using the Simple Clinical Colitis Activity Index (SCCAI). The SCCAI has a total range from 0-19 with a higher score indicating greater disease activity. A clinical response is defined as a SCCAI decrease of ≥3 points from baseline. Therefore, the study team will examine the percentage of patients who achieve 'clinical response', defined by an SCCAI decrease of ≥3 points.
Interventions
- OTHER A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy
- DRUG Advanced therapy only without dietary intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2020-09-18 |
| Est. Completion | 2023-12-07 |
| Phase | Phase 3 |
What the finished NCT04505410 record still lists
NCT04505410 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 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy is the first listed.
NCT04505410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04505410 about?
NCT04505410 is a clinical study titled "Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis". The purpose of this study is to determine whether a diet intervention (the Fasting Mimicking diet) will help induce clinical and biochemical response to an advanced therapy in patients with ulcerative colitis. Study period will be 8 weeks during induction of advanced therapies. The primary aims of t...
What is the current status of trial NCT04505410?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2020-09-18. Estimated completion is 2023-12-07.
What interventions are being tested in trial NCT04505410?
The interventions under investigation include: A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy (OTHER), Advanced therapy only without dietary intervention (DRUG).
Who is sponsoring clinical trial NCT04505410?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04505410's enrollment target sits among peer trials
32 1909th of 2000 higher than 87 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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