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Terminated Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT05480761

Public ClinicalTrials.gov record NCT05480761. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 5:54 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT05480761
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 4
Lead sponsor
QOL Medical, LLC
Industry
Enrollment
312 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Months to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 1, 2022 (Actual)
Primary completion
Sep 18, 2024 (Actual)
Completion
Sep 18, 2024 (Actual)
Last update posted
Mar 20, 2025

2022 – 2024

United States locations

U.S. sites
20
U.S. states
13
U.S. cities
16
Facility City State ZIP Site status
Children's Hospital Los Angeles Los Angeles California 90027 —
UCSF Benioff Children's Hospital Oakland Oakland California 94609 —
Kidz Medical Coral Gables Florida 33146 —
Orlando Health Orlando Florida 32806 —
Children's Healthcare of Atlanta Atlanta Georgia 30329 —
Center for Digestive Health Care, LLC Atlanta Georgia 30342 —
University of Maryland Baltimore Baltimore Maryland 21201 —
Johns Hopkins University Baltimore Maryland 21205 —
GI Associates Flowood Mississippi 39232 —
Happy Tummies Flowood Mississippi 39232 —
Children's Mercy Hospital Kansas City Missouri 64108 —
Atlantic Health System Morristown New Jersey 07960 —
WNY Pediatric Gastroenterology Buffalo New York 14225 —
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 —
Measurable Outcomes Research Oklahoma City Oklahoma 73112 —
Prisma Health Greenville South Carolina 29615 —
GI For Kids, PLLC Knoxville Tennessee 32963 —
Newco 3A Research,LLC DBA 3A Research El Paso Texas 79902 —
Pediatric GI of El Paso, LLC El Paso Texas 79925 —
McGovern Medical School of UT Health Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05480761, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 20, 2025 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05480761 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →