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

STUDY OVERVIEW

This Phase 4, U.S.-only, multi-center study sponsored by QOL Medical aims to assess the response to Sucraid® in 1100 symptomatic pediatric subjects aged 6 months to 17 years with low, moderate, and normal sucrase activity levels determined by disaccharidase assay via EGD within 1 year of screening. It will also investigate the correlation between known genetic CSID mutations and sucrase activities. The study includes various visits and explores the efficacy of Sucraid® in subjects with carbohydrate maldigestion symptoms.

STUDY GOALS

The goal of this Phase 4 study is to evaluate the efficacy of Sucraid® in symptomatic pediatric subjects with varying sucrase activity levels and explore the relationship between genetic CSID mutations and sucrase activities.

LOCATION

El Paso, Texas: 3A Research

INCLUSION CRITERIA

  • Subjects must have undergone a disaccharidase assay (DA) within the last year, with normal results, and are grouped based on sucrase levels.

  • Those suspected of having Congenital Sucrase-Isomaltase Deficiency (CSID) and experiencing frequent gastrointestinal symptoms may be eligible.

  • Subject or guardian consent is required, and subjects must be U.S. residents aged 6 months to 17 years.

  • Willingness to participate in study procedures, including completing electronic questionnaires and attending visits, and ability to understand English.

  • Must have their own Android or Apple device.

exclusion criteria

  • Exclusions include lactating or pregnant females, allergies to certain substances, other conditions causing abdominal pain, recent febrile illness, inability to understand study requirements, recent major illnesses affecting participation, prior use of Sucraid®, and uncontrolled systematic disease.

For more information, visit ClinicalTrials.gov.