Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT03218904
Eligibility Criteria:
Inclusion Criteria:
Experiment 1
* Healthy adults 19 - 35 years of age
* Adults who have no medical conditions
* Adults who currently free from any concurrent illness such as fever or cold
Experiment 2
Healthy Controls:
* Healthy children 5 - 18 years of age
* Healthy adults 19 - 35 years of age
* Children and adults who have no medical conditions
* Children and adults who currently free from any concurrent illness such as fever or cold
Subjects with GSD I:
* Children 5 - 18 years of age who are diagnosed with GSD I
* Adults 19 - 35 years of age who are diagnosed with GSD I
* Clinically stable children and adults with GSD I with no concurrent illness such as fever, cold, vomiting or diarrhea
* Children and adults with GSD I who have had the clinical decision made to start the extended release waxy maize cornstarch Glycosade®
Exclusion Criteria:
Experiment 1
* Healthy adults above age 35 years
* Adults who have a history of cardiovascular disease, liver or kidney disease, metabolic, pulmonary, gastrointestinal or endocrine disorder
* Healthy adults but are currently ill with a fever, cold, vomiting or diarrhea
* Healthy adults with claustrophobia
* Healthy adults currently smoking or consuming more than one drink containing alcohol each day
* Adults currently or recently taking medication or antibiotics
Experiment 2
Healthy Controls:
* Healthy children under age 5 years
* Healthy adults above age 35 years
* Children and adults who have a history of cardiovascular disease, liver or kidney disease, metabolic, pulmonary, gastrointestinal or endocrine disorder
* Healthy children and adults but are currently ill with a fever, cold, vomiting or diarrhea
* Healthy children and adults with claustrophobia
* Children and adults currently or recently taking medication or antibiotics
* Healthy adults currently smoking or consuming more than one drink containing alcohol each day
Subjects with GSD I:
* Children with GSD I under age 5 years
* Adults with GSD I above age 35 years
* Children and adults diagnosed with GSD I, but are currently ill with a fever, cold, vomiting or diarrhea
* Children and adults diagnosed with GSD I, but where the clinical decision has been made not to start on Glycosade®
* Children and adults with GSD I who have claustrophobia
* Children and adults with GSD I currently or recently taking medication or antibiotics
* Adults with GSD I currently smoking or consuming more than one drink containing alcohol each day
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
35 Years
Study:
NCT03218904
Study Brief:
Protocol Section:
NCT03218904