Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328679
Status:
COMPLETED
Last Update Posted:
2008-10-08
First Post:
2006-05-18
Brief Title:
Evaluation of Food Hypersensitivity in ChildrenAdolescents With Functional Dyspepsia
Sponsor:
Childrens Mercy Hospital Kansas City
Organization:
Childrens Mercy Hospital Kansas City
Study Overview
Official Title:
Food-Specific IgE IgG IgG4 Skin Prick Testing and Atopy Patch Testing in ChildrenAdolescents With Functional Dyspepsia A Pilot Study
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to determine if standard and investigational tests used to help diagnose and treat food allergies can provide information that will be useful in determining the cause of dyspepsia and helpful in designing a treatment plan The study will also determine if there is a connection between positive allergy tests and inflammation in the upper abdomen
Detailed Description:
Recurrent abdominal pain is the most common type of pain in school age children and young adolescents Over 80 of these children have pain in the upper abdomen which is diagnosed as functional dyspepsia FD Many of these children are also found to have eosinophilic duodenitis ED ED is a type of inflammation in the lining of the gastrointestinal tract characterized by an increase in eosinophils An increase in intestinal eosinophils is a finding also seen with food allergy upon exposure to the offending antigen The presence of intestinal eosinophilia in ED would suggest an allergic mechanism may be involved in the generation of pain and other symptoms associated with ED Endoscopy and biopsy are used to aid in the identification of ED which often is followed by elimination diets and food challenges to identify the offending allergen This approach is both invasive due to endoscopy and cumbersome due to the complexity and restrictiveness of the elimination diet The value of screening for food hypersensitivities in children with ED has not been well characterized despite the theoretical links between food hypersensitivities gut inflammation and symptoms of dyspepsia The current study will determine if standard and investigational tests used to evaluate food hypersensitivity have the potential to be used as biomarkers to direct treatment of children with ED
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None