Changes in Intestinal Permeability 4 Hours After Gluten Challenge
Ключевые слова
абстрактный
Описание
When a person with celiac disease is exposed to gluten, their immune system attacks their bowel and causes abdominal pain, bloating, and diarrhea. This process takes 24-72 hours to occur. Some people without celiac disease develop similar symptoms when they eat gluten or wheat. Doctors and scientists do not know what causes this sensitivity to gluten. People with celiac disease and non-celiac gluten sensitivity report symptoms within hours of being exposed to gluten. This study evaluates why this occurs by looking at changes in blood, urine, stool, and the bowel after being given gluten.
Даты
| Последняя проверка: | 05/31/2019 |
| Первый отправленный: | 09/17/2017 |
| Предполагаемая регистрация отправлена: | 09/17/2017 |
| Первое сообщение: | 09/19/2017 |
| Последнее обновление отправлено: | 06/04/2019 |
| Последнее обновление опубликовано: | 06/06/2019 |
| Фактическая дата начала исследования: | 10/09/2017 |
| Предполагаемая дата завершения начальной школы: | 10/29/2018 |
| Предполагаемая дата завершения исследования: | 10/29/2018 |
Состояние или болезнь
Вмешательство / лечение
Dietary Supplement: Gluten
Dietary Supplement: Placebo
Фаза
Группы рук
| Рука | Вмешательство / лечение |
|---|---|
| Active Comparator: Normal Subjects, Gluten Drink Normal subjects will drink a solution containing 6 grams of gluten one time. | |
| Placebo Comparator: Normal Subjects, Placebo Drink Normal subjects will drink a solution without gluten one time. | |
| Active Comparator: Celiac Subjects, Gluten Drink Subjects with celiac disease will drink a solution containing 6 grams of gluten one time. | |
| Placebo Comparator: Celiac Subjects, Placebo Drink Subjects with celiac disease will drink a solution without gluten one time. | |
| Active Comparator: Gluten Sensitivity, Gluten Drink Subjects with non-celiac gluten sensitivity will drink a solution containing 6 grams of gluten one time. | |
| Placebo Comparator: Gluten Sensitivity, Placebo Drink Subjects with non-celiac gluten sensitivity will drink a solution without gluten one time. |
Критерии приемлемости
| Возраст, имеющий право на обучение | 18 Years Чтобы 18 Years |
| Полы, имеющие право на обучение | All |
| Принимает здоровых добровольцев | да |
| Критерии | Inclusion Criteria for subjects with Celiac Disease: - Biopsy proven celiac disease diagnosed at least 2 years prior to recruitment - Attest to following a gluten free diet to the best of their ability - Quiescent symptoms on a gluten free diet - Negative tissue transglutaminase at time of recruitment (to be collected with baseline blood work) - A prior endoscopy with small bowel biopsies reviewed by a gastrointestinal pathologist revealing healing Inclusion Criteria for subjects with Non-Celiac Gluten Sensitivity: - Meet diagnostic consensus criteria as defined by Ludvigsson et al in "The Oslo definitions for coeliac disease and related terms" - Attest to following a gluten free diet to the best of their ability - Quiescent symptoms on a gluten free diet - Prior negative evaluation for celiac disease (including tissue transglutaminase IgA with total IgA or small bowel biopsies) - If subjects have had a small bowel biopsies revealing increased intraepithelial lymphocytes (IELs), they will be reviewed as a separate subgroup Inclusion Criteria for Normal Subjects: - No gastrointestinal diagnosis (reflux, eosinophilic esophagitis, inflammatory bowel disease, or irritable bowel syndrome) - No gastrointestinal symptoms (diarrhea, abdominal pain, nausea, vomiting, weight loss) - No family history of celiac disease - Will not be required to have a baseline biopsy Exclusion Criteria: - Tobacco use - Symptomatic coronary disease - Active, severe pulmonary disease - Baseline oxygen requirement - Coagulopathy (INR>1.5) - Mastocytosis - Active H. pylori infection - Treated celiac disease with neutrophilia or eosinophilia secondary to infection - Diabetes (type 1 and type 2) - Crohn's disease or Ulcerative colitis - Microscopic colitis - Dermatitis herpetiformis - Gastroparesis - Pregnant women Subjects exposed to the following medications during their respective time frames will be excluded: - NSAIDs (24 hours) - Leukotriene inhibitors (24 hours) - Mast cell stabilizers (24 hours) - Benzodiazepines (24 hours) - H2 blockers (2 days) - H1 blockers (7 days) - Steroids (systemic or topically active within gastrointestinal tract) (30 days) - Topical steroids (14 days) - Intermittent (up to once weekly) tranquilizer (trazodone, doxepin) use (7 days) - Chronic tricyclic antidepressant or tranquilizer use (trazodone, doxepin) Use of these medications will also be prohibited during the study duration (AAAAI and AAOA). |
Результат
Основные показатели результатов
1. Activation of the Mucosal Innate Immune System after Oral Gluten Challenge [4 hours]
Меры вторичного результата
1. Changes in Mucosal Permeability after Oral Gluten Challenge [Baseline and up to eight hours after gluten or placebo exposure]
2. Detection of Gluten Peptides in Urine and Stool [Baseline and up to 72 hours after gluten or placebo exposure]
3. Rapid Onset Symptom Development after Gluten Exposure [Baseline and up to 72 hours after gluten or placebo exposure]
