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NCT01953354 · ClinicalTrials.gov registry record · Phase 2
Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01953354: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01953354 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01953354, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC.
Primary Outcome
Clinical response is defined as a reduction in the Mayo score of at least 3 points and at least a 30% reduction from Baseline, along with either a decrease from Baseline in the rectal bleeding subscore of more than 1 point or a rectal bleeding subscore of 0 or 1.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Trichuris suis ova (TSO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
Why NCT01953354 stopped before completion
NCT01953354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01953354 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01953354 about?
NCT01953354 is a clinical study titled "Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis". The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC.
What is the current status of trial NCT01953354?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2013-11. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01953354?
The interventions under investigation include: Placebo (BIOLOGICAL), Trichuris suis ova (TSO) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01953354?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01953354's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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