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

Open to people ages 6 months to 17 years

• Subjects with documented disaccharidase assay levels of lactase, sucrase, maltase, and palatinase via EGD disaccharidase assay (DA) performed no more than 1 year prior to enrollment with normal histological interpretation. Eligible subjects will be enrolled 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 least one symptom of diarrhea, abdominal pain, gas/bloating, nausea, or borborygmi at least 3x per week for the past 3 months or more.
• Subject or parent/guardian must provide informed consent/assent prior to any study procedures 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 study procedures including following study instructions, completing electronic questionnaires via a personal mobile device, attending study visits and, in the Investigator'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.

• 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 such as inflammatory bowel disease, celiac disease, eosinophilic gastrointestinal disorder, 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 requirements and are unable to comply.
• Subject has major physical or psychiatric illness within the last 6 months that in the opinion of the investigator would affect the subject's ability to complete the trial.
• Subject has previously used Sucraid®.
• Subject has uncontrolled systematic disease.