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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 is a Phase 3 study that has completed, run by University of Miami. The registered enrollment target is 32 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04505410
The ClinicalTrials.gov registry entry for NCT04505410 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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