Oral AGY for Celiac Disease
Słowa kluczowe
Abstrakcyjny
Opis
The trial will last approximately 6 weeks. Individuals will be screened to ensure they are following a gluten free diet, continue to have mild to moderate symptoms of gluten exposure despite the diet, and have a history of biopsy proven celiac disease. Those meeting this criteria will then have a baseline visit which will include a short physical exam and additional lab work for safety measures, and quality of life questionnaires. They will record their diet and symptoms for 2 weeks, and then return to receive the study medication, which will be taken with all meals. The first dose will be taken in clinic to facilitate observation of any adverse effects. The next visit will be 2 weeks later for blood work and clinic visit, and then again 2 weeks later for the final visit. Participants will be prompted to report any adverse events that occur during the trial period and at the completion of the trial. During the trial period, the study coordinator will phone participants to remind them to complete their questionnaires and to inquire about adverse events. All participants will receive AGY capsules (500 mg per capsule), and will take 2 capsules with each meal.
Outcome measures The primary outcome variable will be the safety (adverse events, lab results, symptoms), which will be measured throughout the study.
The secondary outcome will be ATG antibody levels, which will be measured at each visit.
Daktyle
| Ostatnia weryfikacja: | 09/30/2019 |
| Pierwsze przesłane: | 01/07/2013 |
| Szacowana liczba przesłanych rejestracji: | 01/07/2013 |
| Wysłany pierwszy: | 01/09/2013 |
| Ostatnia aktualizacja przesłana: | 11/21/2019 |
| Ostatnia opublikowana aktualizacja: | 12/12/2019 |
| Data pierwszego przesłania wyników: | 10/14/2018 |
| Data pierwszego przesłania wyników kontroli jakości: | 11/21/2019 |
| Data opublikowania pierwszych wyników: | 12/12/2019 |
| Rzeczywista data rozpoczęcia badania: | 04/30/2014 |
| Szacowana data zakończenia podstawowej działalności: | 07/31/2015 |
| Szacowana data zakończenia badania: | 07/31/2015 |
Stan lub choroba
Interwencja / leczenie
Other: AGY
Faza
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| Experimental: AGY All participants will receive the same, open-label dose of AGY | Other: AGY AGY is a natural health product produced in egg yolks |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
| Płeć kwalifikująca się do nauki | All |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | Inclusion Criteria: - age 18 or over - confirmed diagnosis of Celiac disease by previous biopsy - follow a gluten-free diet (GFD) - have mild to moderate symptoms despite the GFD diet Exclusion Criteria: - diabetic - use of steroids in previous year - current use of ASA/NSAIDs, metronidazole, or misoprostol - excess alcohol intake - egg allergy - history of severe complications of celiac disease or chronic active GI disease - pregnancy |
Wynik
Podstawowe miary wyników
1. Number of Participants for Which Treatment Was Concluded to be Safe [week 6]
Miary wyników wtórnych
1. Number Celiac Disease Related Symptoms in Participants [daily for 6 weeks]
2. Health Related Quality of Life [week 6]
3. ATG Antibody Level [screening through final visit]
