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NCT03409796 · ClinicalTrials.gov registry record · NA
Assessment of Immune Activation and Tolerance in Celiac Disease During Gluten Challenge
A NA study, sponsored by Takeda.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT03409796: Completed NA study, sponsored by Takeda.
NCT03409796 is a NA study that has completed, run by Takeda. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03409796, a NA study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
The primary purpose of this study is to characterize changes in gluten-specific T cells and pathology in the small intestine with specific focus on biomarkers likely to change with therapeutic celiac disease (CeD) treatment.
Primary Outcome
Attenuation of the effects of gluten exposure was assessed by measuring the change from baseline in villous height (Vh) to crypt depth (Cd) ratio after 15 days of gluten challenge. Villi were the small finger like projections that line the small intestine and promote nutrient absorption and are often shortened in participants with CeD. Crypts were grooves between the villi that are often elongated in participants with CeD. A decreased Vh:Cd ratio indicates more extreme CeD disease symptoms. Base
Interventions
- DIETARY_SUPPLEMENT Gluten
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-04-24 |
| Est. Completion | 2019-05-02 |
| Phase | NA |
What the finished NCT03409796 record still lists
NCT03409796 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 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Gluten is the first listed.
NCT03409796 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03409796 about?
NCT03409796 is a clinical study titled "Assessment of Immune Activation and Tolerance in Celiac Disease During Gluten Challenge". The primary purpose of this study is to characterize changes in gluten-specific T cells and pathology in the small intestine with specific focus on biomarkers likely to change with therapeutic celiac disease (CeD) treatment.
What is the current status of trial NCT03409796?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2018-04-24. Estimated completion is 2019-05-02.
What interventions are being tested in trial NCT03409796?
The interventions under investigation include: Gluten (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03409796?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03409796's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 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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