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NCT03288831 · ClinicalTrials.gov registry record · NA
Changes in Intestinal Permeability 4 Hours After Gluten Challenge
A NA study of Celiac Disease and Gluten Sensitivity, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03288831: Completed NA study of Celiac Disease and Gluten Sensitivity, sponsored by Mayo Clinic.
NCT03288831 is a NA study of Celiac Disease and Gluten Sensitivity that has completed, run by Mayo Clinic. The registered enrollment target is 60 participants, below the 1,978-participant average among 24 other Celiac Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03288831, a NA study of Celiac Disease and Gluten Sensitivity, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates why people with celiac disease and non-celiac gluten/wheat sensitivity develop rapid onset symptoms within hours of gluten exposure. Half of subjects will be given gluten and half will not.
Primary Outcome
Small bowel biopsies will be assessed for markers of innate immune system activation: presence of granulocytes, granulocyte degranulation, products of degranulation, interleukins and cytokines involved in the innate immune system response, inflammatory mediators.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Gluten
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-10-10 |
| Est. Completion | 2018-10-30 |
| Phase | NA |
What the finished NCT03288831 record still lists
NCT03288831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,978-participant average among 24 other Celiac Disease trials with a reported enrollment target (97% lower).
The record links to 6 conditions, with Celiac Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03288831 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03288831 about?
NCT03288831 is a clinical study titled "Changes in Intestinal Permeability 4 Hours After Gluten Challenge". This study evaluates why people with celiac disease and non-celiac gluten/wheat sensitivity develop rapid onset symptoms within hours of gluten exposure. Half of subjects will be given gluten and half will not.
What is the current status of trial NCT03288831?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2017-10-10. Estimated completion is 2018-10-30.
What conditions does trial NCT03288831 study?
This clinical trial studies the following conditions: Celiac Disease, Gluten Sensitivity, Immune System and Related Disorders, Wheat Hypersensitivity, Gluten Enteropathy.
What interventions are being tested in trial NCT03288831?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Gluten (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03288831?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03288831 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03288831's enrollment target sits among peer trials
60 15th of 24 higher than 10 of 24 other Celiac Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Celiac Disease 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.
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