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NCT Number: NCT01854242

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

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.

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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Glycogen Storage Disease Type IA Hepatorenal form of glycogen storage disease Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida and Shands

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glycogen Storage Disease type Ia patients

Other

The participants will have one blood draw for this study. The test will be performed on the blood.

Other names: GSD Type Ia

Primary outcomes

  1. Serologic, Genetic and Inflammatory Markers Consistent With Inflammatory Bowel Disease

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Prometheus Laboratories

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 15, 2013
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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