Pancreatic Enzyme Supplementation for Celiac Disease

Inclusion Criteria:

- Biopsy proven celiac disease.

- Age 18-80.

- Ongoing symptoms defined as a CeD-GSRS score of greater than 3 during the run in
period.

- Subject must be following a gluten free diet.

- tTG < 40 units at screening.

Exclusion Criteria:

- Taking prescription or over the counter enzyme supplements for 1 month prior to
enrollment.

- Pregnant, breastfeeding or planning pregnancy. Woman using acceptable methods of
contraception will be included. Acceptable methods of contraception include oral
hormonal contraceptives, implanted hormonal contraceptives, diaphragm with spermicide,
condoms, intra-uterine device, abstinence, and male partner vasectomy.

- Patients with a pork allergy or who are unwilling to consume pork products.

- English proficiency unsuitable for completion of surveys.

- Known severe pancreatic disease.

- Known history of prior cancer (except squamous or basal cell skin cancer).

- Patients with lactose intolerance who are unable to tolerate a minimum of 1oz (2
tablespoons) of whole milk per day.

- Clinically significant abnormality in safety lab values (i.e. CBC and BMP) at
screening that may impact subject safety or the scientific integrity of the study.

- Other known active GI condition including but not limited to inflammatory bowel
disease, small intestine bacterial overgrowth, and obvious FODMAP intolerance.

- History of all major gastrointestinal surgery other than appendectomy or
cholecystectomy.

- Comorbid condition that in the opinion of the investigator would interfere with the
subject's participation in the study or would confound the results of the study.