Oral AGY for Celiac Disease
Mots clés
Abstrait
La description
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.
Rendez-vous
| Dernière vérification: | 09/30/2019 |
| Première soumission: | 01/07/2013 |
| Inscription estimée soumise: | 01/07/2013 |
| Première publication: | 01/09/2013 |
| Dernière mise à jour soumise: | 11/21/2019 |
| Dernière mise à jour publiée: | 12/12/2019 |
| Date des premiers résultats soumis: | 10/14/2018 |
| Date de la première soumission des résultats du CQ: | 11/21/2019 |
| Date des premiers résultats publiés: | 12/12/2019 |
| Date de début réelle de l'étude: | 04/30/2014 |
| Date d'achèvement primaire estimée: | 07/31/2015 |
| Date estimée d'achèvement de l'étude: | 07/31/2015 |
Condition ou maladie
Intervention / traitement
Other: AGY
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| 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 |
Critère d'éligibilité
| Âges éligibles aux études | 18 Years À 18 Years |
| Sexes éligibles à l'étude | All |
| Accepte les bénévoles en santé | Oui |
| Critères | 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 |
Résultat
Mesures des résultats primaires
1. Number of Participants for Which Treatment Was Concluded to be Safe [week 6]
Mesures des résultats secondaires
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]
