The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic
enzyme supplementation will improve symptoms in individuals with celiac disease who suffer
persistent symptoms despite a gluten free diet. This protocol specifically aims to:
1. Evaluate the efficacy of pancreatic enzyme supplementation for reduction of
gastrointestinal symptoms in patients with celiac disease on a gluten free diet.
2. Assess the ability of fecal elastase levels to predict response to pancreatic enzyme
supplementation in patients with celiac disease on a gluten free diet.
- Biopsy proven celiac disease.
- Age 18-80.
- Ongoing symptoms defined as a CeD-GSRS score of greater than 3 during the run in
- Subject must be following a gluten free diet.
- tTG < 40 units at screening.
- Taking prescription or over the counter enzyme supplements for 1 month prior to
- 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
- 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.