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

Brief Title

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

Official Title

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

Brief 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.
    

Detailed 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.
    


Study Type

Observational


Primary Outcome

Serologic, Genetic and Inflammatory Markers Consistent With Inflammatory Bowel Disease


Condition

Inflammatory Bowel Disease

Intervention

Glycogen Storage Disease type Ia patients

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

50

Start Date

November 2013

Completion Date

October 2014

Primary Completion Date

October 2014

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Nicole T Lawrence, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01854242

Organization ID

IRB201300312

Secondary IDs

COL13IBD01

Responsible Party

Sponsor

Study Sponsor

University of Florida

Collaborators

 Prometheus Laboratories

Study Sponsor

Nicole T Lawrence, MD, Principal Investigator, University of Florida


Verification Date

February 2019