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

Stopped early · Phase 4

Conditions studied: Congenital Sucrase-Isomaltase Deficiency, CSID, Sucrase Isomaltase Deficiency

In brief

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).

Key facts

Study ID: NCT05480761
Run by: QOL Medical, LLC
People needed: 312
Starts: 2022-08-01
Expected to finish: 2024-09-18
Last updated by the study team: 2025-03-20

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects with documented disaccharidase assay levels of lactase, sucrase, maltase, and palatinase via EGD disaccharidase assay (DA) performed no more than 1 year prior to enrollment with normal histological interpretation. Eligible subjects will be enrolled into the following study groups based on their documented sucrase level.
DA Sucrase < 25 (n=500)
DA Sucrase 25-35 (n=500)
DA Sucrase >55 (n=100)
At the discretion of the investigator, subject is suspected of CSID and has at least one symptom of diarrhea, abdominal pain, gas/bloating, nausea, or borborygmi at least 3x per week for the past 3 months or more.
Subject or parent/guardian must provide informed consent/assent prior to any study procedures being performed.
Subject is a U.S. resident.
Subject is male or female, ages 6 months to 17 years old.
Subject/parent or guardian is willing and able to complete necessary study procedures including following study instructions, completing electronic questionnaires via a personal mobile device, attending study visits and, in the Investigator's judgment, is sufficiently stable to participate in the study.
Subject/ parent or guardian must be able to read or understand the English language.
Subject or parent/guardian must have their own Android or Apple device for BYOD.

You may not qualify if…

Females who are lactating or pregnant.
Subjects with allergy to sucrose, yeast, papain, or glycerol.
Subjects with causes of abdominal pain or altered bowel habits other than CSID such as inflammatory bowel disease, celiac disease, eosinophilic gastrointestinal disorder, pancreatitis, or gastrointestinal bleeding.
Subjects with a history of diabetes mellitus.
Subjects with a recent febrile illness (5 days prior to study).
Subjects that do not have the mental capacity to understand the study requirements and are unable to comply.
Subject has major physical or psychiatric illness within the last 6 months that in the opinion of the investigator would affect the subject's ability to complete the trial.
Subject has previously used Sucraid®.
Subject has uncontrolled systematic disease.

Where it is running

Children's Hospital Los Angeles — Los Angeles, California, United States
UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
Kidz Medical — Coral Gables, Florida, United States
Orlando Health — Orlando, Florida, United States
Children's Healthcare of Atlanta — Atlanta, Georgia, United States
Center for Digestive Health Care, LLC — Atlanta, Georgia, United States
University of Maryland Baltimore — Baltimore, Maryland, United States
Johns Hopkins University — Baltimore, Maryland, United States
GI Associates — Flowood, Mississippi, United States
Happy Tummies — Flowood, Mississippi, United States
Children's Mercy Hospital — Kansas City, Missouri, United States
Atlantic Health System — Morristown, New Jersey, United States
WNY Pediatric Gastroenterology — Buffalo, New York, United States
University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
Measurable Outcomes Research — Oklahoma City, Oklahoma, United States
Prisma Health — Greenville, South Carolina, United States
GI For Kids, PLLC — Knoxville, Tennessee, United States
Newco 3A Research,LLC DBA 3A Research — El Paso, Texas, United States
Pediatric GI of El Paso, LLC — El Paso, Texas, United States
McGovern Medical School of UT Health — Houston, Texas, United States

Full record on ClinicalTrials.gov

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