At a glance
ClinicalIndex Comparison RecordN/ACompleted· 60 enrolled
Drug / intervention
Gluten +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Innate Response to and Changes in Intestinal Permeability 4 Hours After a Gluten Challenge in Subjects With Celiac Disease and Non Celiac Gluten Sensitivity
In Brief
A clinical study evaluating Gluten and Placebo for Celiac Disease and 5 related conditions. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCeliac Disease, Wheat Hypersensitivity, Gluten Sensitivity, Gluten Enteropathy, Immune System and Related Disorders, Duodenal Diseases
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartOct 2017
Primary CompletionOct 2018
TodayJul 2026
First PostedSep 20, 2017
Enrollment StartOct 10, 2017
Primary CompletionOct 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.8 years ago
Interventions
Glutendietary
Six grams of gluten will be mixed with water and Tang flavoring. Subjects will drink the mixture one time.
Placebodietary
Subjects will drink a mixture of rice water and Tang flavoring one time.