7-Day Trial of Sucraid for Alleviating CSID Symptoms in Subjects With Low, Moderate, and Normal Sucrase Levels

Inclusion Criteria:

• Subjects with documented disaccharidase assay levels of lactase, sucrase, maltase,and palatinase via EGD disaccharidase assay (DA) performed no more than 1 year priorto enrollment with normal histological interpretation. Eligible subjects will beenrolled into the following study groups based on their documented sucrase level.

• DA Sucrase < 25 (n=500)

• DA Sucrase 25-35 (n=500)

• DA Sucrase >55 (n=100)

• At the discretion of the investigator, subject is suspected of CSID and has at leastone symptom of diarrhea, abdominal pain, gas/bloating, nausea, or borborygmi atleast 3x per week for the past 3 months or more.

• Subject or parent/guardian must provide informed consent/assent prior to any studyprocedures being performed.

• Subject is a U.S. resident.

• Subject is male or female, ages 6 months to 17 years old.

• Subject/parent or guardian is willing and able to complete necessary studyprocedures including following study instructions, completing electronicquestionnaires via a personal mobile device, attending study visits and, in theInvestigator's judgment, is sufficiently stable to participate in the study.

• Subject/ parent or guardian must be able to read or understand the English language.

• Subject or parent/guardian must have their own Android or Apple device for BYOD.

Exclusion Criteria:

• Females who are lactating or pregnant.

• Subjects with allergy to sucrose, yeast, papain, or glycerol.

• Subjects with causes of abdominal pain or altered bowel habits other than CSID suchas inflammatory bowel disease, celiac disease, eosinophilic gastrointestinaldisorder, pancreatitis, or gastrointestinal bleeding.

• Subjects with a history of diabetes mellitus.

• Subjects with a recent febrile illness (5 days prior to study).

• Subjects that do not have the mental capacity to understand the study requirementsand are unable to comply.

• Subject has major physical or psychiatric illness within the last 6 months that inthe opinion of the investigator would affect the subject's ability to complete thetrial.

• Subject has previously used Sucraid®.

• Subject has uncontrolled systematic disease.