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

NCT05480761 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2025-03-20

No results posted yet for this study

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).

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • QOL Medical, LLC

    lead INDUSTRY

Principal Investigators

  • Weng Tao, M.D., Ph. D · QOL Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2024-09-18
Completion
2024-09-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05480761 on ClinicalTrials.gov