Oral AGY for Celiac Disease
关键词
抽象
描述
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.
日期
| 最后验证: | 09/30/2019 |
| 首次提交: | 01/07/2013 |
| 提交的预估入学人数: | 01/07/2013 |
| 首次发布: | 01/09/2013 |
| 上次提交的更新: | 11/21/2019 |
| 最近更新发布: | 12/12/2019 |
| 首次提交结果的日期: | 10/14/2018 |
| 首次提交质量检查结果的日期: | 11/21/2019 |
| 首次发布结果的日期: | 12/12/2019 |
| 实际学习开始日期: | 04/30/2014 |
| 预计主要完成日期: | 07/31/2015 |
| 预计完成日期: | 07/31/2015 |
状况或疾病
干预/治疗
Other: AGY
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Number of Participants for Which Treatment Was Concluded to be Safe [week 6]
次要成果指标
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]
