The Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64108, United States
NCT Number: NCT00328679
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.
Looking for future studies?
Notify Me8 year–17 year
All sexes
Interventional
Phase 1
Kansas City, Missouri, 64108, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(patient goup):
Exclusion criteria
(healthy control group)
Patch Test: food to be tested is suspended in sterile saline, placed on the skin of the back using a Finn Chamber secured with surgical tape and left in place for 48 hours.
Time frame: 48 hrs and 72 hrs after patch placement
Time frame: collected at time of biopsy, patient group only
Children's Mercy Hospital Kansas City
Other
Food-Specific IgE, IgG, IgG4, Skin Prick Testing and Atopy Patch Testing in Children/Adolescents With Functional Dyspepsia: A Pilot Study
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.
Published trials that share one or more normalized conditions with this study.
NCT05810168
Digestive System Diseases, Dyspepsia
Sheffield, South Yorkshire, United Kingdom
View Trial DetailsNCT05004012
Digestive System Diseases, Dyspepsia
Los Angeles, California, United States
View Trial DetailsNCT06760897
Dysbiosis, Dyspepsia
Guangzhou, Guangdong, China
View Trial DetailsNCT06150638
Colonic Diseases, Colonic Diseases, Functional
Barcelona, Spain
View Trial Details