Oral AGY for Celiac Disease

NCT01765647 | Completed Phase 1 Results

• 1 other identifier: AGY
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Celiac Disease

Keywords

Celiac disease; AGY

Outcome Measures

Primary Outcomes (1)

• Number of Participants for Which Treatment Was Concluded to be Safe

  Measures include: adverse events, serious adverse events, withdrawal due to adverse events, abnormal lab results

  week 6

Secondary Outcomes (3)

• Number Celiac Disease Related Symptoms in Participants

  daily for 6 weeks

• Health Related Quality of Life

  week 6

• ATG Antibody Level

  screening through final visit

Study Arms (1)

AGY

EXPERIMENTAL

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

Other: AGY

Interventions

AGY OTHER

AGY is a natural health product produced in egg yolks

AGY

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Igy Inc.: lead
• University of Alberta: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2X8, Canada

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dory Sample
• Organization: University of Alberta

dory.sample@ahs.ca

780-248-5599

Study Officials

• Leo Dieleman

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants received open label AGY, a natural health product

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 10, 2013
• Study Start: May 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 13, 2019
• Results First Posted: December 13, 2019

Record last verified: 2019-10

Locations

CA (1)