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NCT04065048 · ClinicalTrials.gov registry record · NA
A Dietary Intervention Study on the Microbiome in Crohn's Disease Patients
A NA study, sponsored by Case Western Reserve University.
- Completed
- Registry status
- NA
- Development phase
- 67
- Enrollment target
NCT04065048: Completed NA study, sponsored by Case Western Reserve University.
NCT04065048 is a NA study that has completed, run by Case Western Reserve University. The registered enrollment target is 67 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04065048, a NA study, has completed, sponsored by Case Western Reserve University.
- COMPLETED
- Registry status
- NA
- Development phase
- 67 participants
- Enrollment target
Study Summary
This protocol is designed to compare the effectiveness of a soy-based diet or identical diet without soy given to patients with Crohn's disease (CD) in remission, patients with active CD, or healthy controls. The assigned diet will be compared to participant 'baseline' (pre-diet) in terms of its ability to change the gut bacteria and fecal butyrate, an important short-chain fatty acid (SCFA) that limits bowel inflammation, a characteristic of this debilitating disease.
Primary Outcome
The primary aim will measure the Crohn's Disease Activity Index (CDAI) at the enrollment and end of study visit. CDAI scores can range from 0 to \~600 (A score of less than 150 corresponds to relative disease quiescence (remission); 150 to 219, mildly active disease; 220 to 450, moderately active disease; and greater than 450, severe disease). Herein, a cut-off value of \<150 was selected so that most patients below this threshold would be rated by physicians as 'very well'. Change was calculate
Interventions
- OTHER Soy based diet
- OTHER Non-soy based diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2023-10-10 |
| Phase | NA |
What the finished NCT04065048 record still lists
NCT04065048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Soy based diet is the first listed.
NCT04065048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04065048 about?
NCT04065048 is a clinical study titled "A Dietary Intervention Study on the Microbiome in Crohn's Disease Patients". This protocol is designed to compare the effectiveness of a soy-based diet or identical diet without soy given to patients with Crohn's disease (CD) in remission, patients with active CD, or healthy controls. The assigned diet will be compared to participant 'baseline' (pre-diet) in terms of its abi...
What is the current status of trial NCT04065048?
This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 2019-11-01. Estimated completion is 2023-10-10.
What interventions are being tested in trial NCT04065048?
The interventions under investigation include: Soy based diet (OTHER), Non-soy based diet (OTHER).
Who is sponsoring clinical trial NCT04065048?
This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04065048's enrollment target sits among peer trials
67 1139th of 2000 higher than 862 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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