Sucraid for Congenital Sucrase-Isomaltase Deficiency

Recruiting at19 trial locations

Overseen by Weng Tao, M.D., Ph. D

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: QOL Medical, LLC

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests Sucraid®, a medication that helps break down sugars, in children with digestive issues due to low sucrase levels. It aims to see if Sucraid® can reduce symptoms like diarrhea and stomach pain by providing the enzyme needed to digest sugar.

Research Team

Weng Tao, M.D., Ph. D

Principal Investigator

QOL Medical

Eligibility Criteria

This trial is for U.S. children aged 6 months to 17 years with low, moderate, or normal sucrase levels as shown by a test within the last year. They must not have used Sucraid before and should be free from major illnesses or conditions like diabetes that could affect their participation.

Inclusion Criteria

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

Participants will be grouped based on their sucrase levels into three groups: low sucrase (<25), medium sucrase (25-35), and high sucrase (>55).

I have symptoms like diarrhea or abdominal pain at least 3 times a week for the last 3 months.

Exclusion Criteria

I have a history of diabetes.

I have a disease that is not currently under control.

I have not had a fever or flu-like symptoms in the last 5 days.

Treatment Details

Interventions

• Sucraid (Enzyme Replacement Therapy)

Trial Overview The study tests how effective a 7-day treatment of Sucraid (sacrosidase) Oral Solution is in kids with different levels of sucrase enzyme activity. It also looks at the link between genetic mutations related to CSID and sucrase activity levels.

Participant Groups

Group I: Single Arm Open Labeled Commercial Sucraid Experimental Treatment 1 Intervention

All subjects will complete a 7-day treatment period of open-labeled FDA approved commercial Sucraid.

Who Is Running the Clinical Trial?

QOL Medical, LLC

Lead Sponsor

Trials

6

Recruited

600+