NCT05045495

Adult Pilot Study for Reference Ranges and Optimal Cut-offs for the Sucrose Challenge Test and Sucrose Breath Test

Adult Pilot Study to Establish the Reference Ranges and Optimal Cut-offs for Oral 50g Sucrose Challenge Test & 13C-Sucrose Breath Test for CSID Cases (Previously Diagnosed Sucraid Responders) & Controls (GI Asymptomatic Healthy Volunteers)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 211 (actual)
• Sponsor: QOL Medical, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

An adult pilot study to establish the normal reference range and optimal cutoffs for the oral 50g Sucrose Challenge Test (SCT) and the 50g 13C-Sucrose Breath Test (CBT) for patients with CSID and healthy controls. This study will enroll 120 healthy controls and 50 CSID patients. No study drug will be administered during this study.

Detailed description

In an effort to mimic the real-world diagnostic setting for these tests, this study will be conducted virtually using a central site with telemedicine capabilities and electronic data capture software to collect data in real time via a mobile app. Subject will complete 3 visits within 21 days. Eligible subjects will undergo the following tests: 1. 50g 13C-Sucrose Breath Test (CBT) 2. Sucrose Intolerance Hydrogen Methane Breath Test (HBT) 3. Sucrose Challenge Test (SCT) 4. Buccal swab for CSID Genetic Testing (GT) The primary aim is to establish the reference/normal ranges and optimal cutoff values for the SCT and CBT.

Conditions

• Congenital Sucrase-Isomaltase Deficiency

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Sucrose Hydrogen Methane Breath Test	Subjects will collect 2 buccal swabs for the sucrase genetic test and then subjects will simultaneously conduct the sucrose challenge test, sucrose hydrogen methane breath test, and the 13C-sucrose following ingestion of 50-grams of sucrose (table sugar) mixed with 8 ounce of water.

Timeline

• Start date: 2021-08-30
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2021-09-16
• Last updated: 2022-05-24

Locations

1 site across 1 country: United States