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

NCT05045495 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 211

Last updated 2022-05-24

No results posted yet for this study

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.

Conditions

  • Congenital Sucrase-Isomaltase Deficiency

Interventions

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.

Sponsors & Collaborators

  • QOL Medical, LLC

    lead INDUSTRY

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-30
Primary Completion
2022-02-28
Completion
2022-02-28

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 NCT05045495 on ClinicalTrials.gov