Oral AGY for Celiac Disease

Phase 1

Completed

Conditions: Celiac Disease

Interventions: Other: AGY

Registration Number: NCT01765647

Lead Sponsor: Igy Inc.

Brief Summary: Celiac disease (CD) is an autoimmune disease of the small intestine caused by the consumption of gluten proteins from widely used food sources such as wheat, rye, and barley. Exposure of the small intestine to gluten causes an inflammatory response, leading to the destruction of intestine lining, often with severe symptoms including diarrhea, abdominal distention, fatigue, weight loss, anemia, and neurological symptoms. CD is a lifelong disease and the only treatment currently available is strict adherence to a life-time gluten free diet (GFD). However, adhering to this diet is difficult as gluten proteins are found in many food products. Therefore, the gluten-free diet has both lifestyle and financial implications for the individual and thus has been potential for impacting adversely on their quality of life.

Various approaches are being studied to reduce the need for careful control of the diet for those with CD, including the use of antibodies such as IgY. IgY is produced from the egg yolks of super immunized laying hens. Egg yolk antibodies are natural products with minimal toxicity, for those without egg allergy, and offer low-cost, hygienic production of study product. Once the IgY antibody is put into capsule form, it is called AGY.

Individuals with CD will be recruited only if they have a history of biopsy proven CD, currently follow a GFD but continue to have mild to moderate symptoms related to gluten exposure, and do not have an egg allergy. Blood will be tested for ATG antibody levels at screening. Those enrolled will have a 2 week run-in period where diet and symptoms are recorded, and will then receive AGY capsules to take with meals over a 4 week period. Outcomes will be measured by examining lab test results including antibody levels, symptoms, and quality of life.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AGY	AGY	All participants will receive the same, open-label dose of AGY

Primary Outcome Measures

Name	Time	Method
Number of Participants for Which Treatment Was Concluded to be Safe	week 6	Measures include: adverse events, serious adverse events, withdrawal due to adverse events, abnormal lab results

Secondary Outcome Measures

Name	Time	Method
Health Related Quality of Life	week 6	health related quality of life will be measured at 4 time points using a validated tool; (short form 36; SF-36) baseline, week 2, week 4, and at the end of the study at week 6. Scores can range from 20-80, with 50 being a population norm. Therefore, a score above 50 indicates better than the general population norm, and a score below 50 indicates worse than the population norm.
ATG Antibody Level	screening through final visit	The ATG antibody level will be measured at baseline, week 2, week 4 and week 6. Normal values are less than 7; elevated values mean a worse outcome. Assessed at baseline, week 2, week 4 and week 6; baseline and week 6 reported.
Number Celiac Disease Related Symptoms in Participants	daily for 6 weeks	Symptoms of Celiac disease will be self-measured by participants daily for the entire 6 week study period using the Celiac Symptom Index tool.