NCT05480761

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

Evaluation of a 7-Day Therapeutic Trial Dose of Commercial Sucraid® (Sacrosidase) Oral Solution for Alleviating Congenital Sucrase-Isomaltase Deficiency (CSID) Symptoms in Pediatric Subjects With Low, Moderate, and Normal Sucrase Levels

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: QOL Medical, LLC · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 4, U.S. only, multi-center study using a 7-day therapeutic response dose (TRD) of commercial Sucraid® to assess the response of treatment in 1100 symptomatic pediatric (6 months to 17 years old) subjects with low, moderate, and normal sucrase activity determined by a disaccharidase assay via EGD within 1 year of the Screening Visit. This study will also explore the relationship between known genetic CSID mutations and sucrase activities via (EGD) disaccharidase assay (low, moderate, and normal).

Detailed description

This phase 4 study will evaluate the response to Sucraid® in pediatric subjects aged 6 months to 17 years old with low (\< 25 µM/min/gram protein), moderate (25-35 µM/min/gram protein), and normal (\> 55 µM/min/gram protein) sucrase activities. Subjects with a sucrase level via disaccharidase assay from an EGD within 1 year of informed consent/assent, a normal histological interpretation, and at the discretion of the investigator, at least one symptom of carbohydrate maldigestion (CMS) of postprandial diarrhea, abdominal pain, gas/bloating, or defecation urgency at least 3 times per week for the past 3 months or more will be eligible for study participation. This study will also explore the relationship between three groups of sucrase levels from the EGD disaccharidase assay and the genetic test. This study will consist of a Screening Visit, Run-in Period, Baseline Visit, Treatment Period, and Follow-up Visit.

Conditions

• Congenital Sucrase-Isomaltase Deficiency
• CSID
• Sucrase Isomaltase Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	Sucraid (sacrosidase) Oral Solution 8500 IU/mL	Sucraid is a pale yellow to colorless, clear solution of glycerol, water, and citric acid, with a pleasant, sweet taste. Each milliliter of Sucraid contains 8,500 IU of the enzyme sacrosidase, the active ingredient.

Timeline

• Start date: 2022-08-01
• Primary completion: 2024-09-18
• Completion: 2024-09-18
• First posted: 2022-07-29
• Last updated: 2025-03-20

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study