Study Details
Testing SSDXP-13 a Study Drug for People with Congenital Sucrase-Isomaltase Deficiency
(IRB#: IRB_00165049)
Congenital Sucrase-Isomaltase Deficiency CSID is a genetic condition that can affect a person's ability to digest sugars, such as sucrose (a naturally occurring sugar found in fruits and known as table sugar) and maltose (the sugar found in grains). This study will test the study drug SSDXP-13 for people who have CSID. The study wants to see if the drug will help people with this disease and is safe. The study is for parents and their children. Children ages 6 months to 17 years old will take the study drug as a mixture added to water or milk. Being in the study requires completing surveys on the cell phone during the treatment. People in the study will attend both in-person visits at the study clinic and some visits can be over the phone or telehealth on a device such as a computer. Medical tests will be done during the study to learn and track the health of participants.
- All genders
- Under 18 years old
- Healthy Volunteers
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Under 18 years old
Volunteers: Healthy Volunteers
Location: In Person
Inclusion Criteria
- Ages 6 months to 17 years old. Those who are 17 turning 18 may still be eligible for participation.
- Parent/Caregiver of the child
- Diagnosis of CSID with at least one certain symptom such as diarrhea, stomach pain, or nausea at least 3 times a week for the prior 3 months or more of participation
- Consistent access to a mobile device such as a cellphone to complete surveys
- Attend in-person at the study clinic
Exclusion Criteria
- Pregnant or breastfeeding
- Allergy to sucrose, yeast, papain, or glycerol
- History of diabetes
- Major health issue within 6 months before participation
- Bowel or gut conditions that already cause abdominal pain or altered bowel habits, such as inflammatory bowel disease, celiac disease, pancreatitis.
Will I be paid for my time?
Yes
IRB#: IRB_00165049
PI: Molly O'Gorman
Department: PEDIATRICS
Approval Date: 2023-09-20 06:00:00
Specialties: Pediatric Nephrology