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

NCT ID: NCT05045495

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 211 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2022-02-28

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Volunteer

120 Healthy Volunteers will perform the 50-gram sucrose challenge test, Sucrose hydrogen methane breath test, 13C-sucrose breath test and collect buccal swab samples for genetic testing.

Sucrose Hydrogen Methane Breath Test

Intervention Type: DIAGNOSTIC_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.

CSID Case

50 CSID cases defined by being on Sucraid for at least 12 months will perform the 50-gram sucrose challenge test, Sucrose hydrogen methane breath test, 13C-sucrose breath test and collect buccal swab samples for genetic testing.

Sucrose Hydrogen Methane Breath Test

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

13C-Sucrose Breath Test; Sucrase Genetic Test (Buccal Swab); Sucrose Challenge Test

Eligibility Criteria

Inclusion Criteria

• Subject must provide informed consent prior to any study procedures being performed.
• Subject is a U.S. resident, and speaks and understands English
• Subject is male or female, ≥ 18 years old.
• CSID Cases must have been on Sucraid for at the last 12 months.
• Healthy Volunteers do not have a CSID diagnosis or other chronic gastrointestinal conditions.
• Subject must have their own Android or Apple device to access the mobile patient app.

Exclusion Criteria

• Females who are lactating or pregnant.
• Subjects with allergy to sucrose.
• Subjects with causes of abdominal pain or altered bowel habits other than symptoms -related to CSID (in CSID group) such as SIBO, IBD, celiac disease, pancreatitis, or -gastrointestinal bleeding.
• Diabetes mellitus.
• Use of systemic antibiotics, had a barium study, colonoscopy, unexplained runny diarrhea, or similar within 14 days prior to informed consent. Potential subjects can be re-screened once they meet this criterion.
• Recent febrile illness.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

QOL Medical, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weng Tao, M.D., Ph. D

Role: PRINCIPAL_INVESTIGATOR

QOL Medical

Locations

Science 37-Recruiting Nationally

Culver City, California, United States

Countries

United States

Other Identifiers

SSDXA-12

Identifier Type: -

Identifier Source: org_study_id