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NCT01854242 Clinical Trial

Study of the Relationship Between Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease

Inflammatory Bowel Disease Clinical Trial

Official title:
Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease: A New Comorbidity or Secondary Consequence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01854242
Other study ID # IRB201300312
Secondary ID COL13IBD01
Status Completed
Phase
First received
Last updated
Start date November 2013
Est. completion date October 2014

Study information
Verified date February 2019
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this research study is to understand the relationship between inflammatory bowel disease (IBD) and Glycogen storage disease (GSD)type Ia. GSD type Ib has been established to have an association with IBD with clinical and histologic features that mirror those of Crohn disease. Development of the disease seems to be related to the defect of neutrophil function in individuals with GSD type Ib and subsequent colonic inflammation. In the last decade, it has become a standard for patients with GSD type Ib and gastrointestinal symptoms to be evaluated for IBD. Patients with GSD type Ia were not recognized to have similar gastrointestinal symptoms until recently. The prevalence of IBD is greater in patients with GSD type Ia versus the general population.

Description:

The purpose of this research study is to understand the relationship between IBD and GSD type Ia. The Investigators will be attempting to develop a blood test which will be aimed at the participants diagnosis of IBD.

As a participant in this research study, a blood sample will be collected during your admission to the University of Florida. This will not affect the length of stay of your scheduled visit. There will be no scheduled clinic follow-up.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Anyone with Glycogen Storage Disease type Ia

Exclusion Criteria:

- Anyone where the amount of blood needed to complete the Prometheus test exceeds 3ml/kg.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Glycogen Storage Disease type Ia patients
The participants will have one blood draw for this study. The test will be performed on the blood.

Locations
Country Name City State
United States University of Florida and Shands Gainesville Florida

Sponsors (2)
Lead Sponsor Collaborator
University of Florida Prometheus Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serologic, Genetic and Inflammatory Markers Consistent With Inflammatory Bowel Disease Participants who tested positive for Crohn disease, ulcerative colitis, or unspecified inflammatory bowel disease (IBD) on a panel for IBD are reported in the Outcome Measure Data Table. 2 weeks
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