Clinical trial NCT00328679: Evaluation of Food Hypersensitivity in Children/Adolescents With Functional Dyspepsia
Official title: Food-Specific IgE, IgG, IgG4, Skin Prick Testing and Atopy Patch Testing in Children/Adolescents With Functional Dyspepsia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyspepsia
Keywords: abdominal
stomach
dyspepsia
food allergy
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2006-05-22
Enrollment: 41
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Age of 8-17 years, inclusive
* Diagnosis of functional dyspepsia (FD) by physician based on Rome II criteria (patient group only)
* Undergoing endoscopy to evaluate FD following demonstration of a lack of clinical response to acid reduction therapy (patient group only)
* Informed permission/assent

Exclusion Criteria (patient goup):

* Previous testing for food-specific IgE, IgG, IgG4, skin prick or allergy patch tests within the past 12 months or any previous positive result(s) for food-specific IgE, IgG, IgG4, SPT or APT to milk, egg, soy, corn, peanut or wheat;
* Any use of steroids or leukotriene receptor antagonists within one month prior to the study
* Any use of antihistamines, antihistamine-like drugs or topical steroid within two weeks prior to the study
* Any chronic non-gastrointestinal illness requiring regular medical care

Exclusion Criteria (healthy control group)

* In addition to patient exclusion criteria as defined above
* Any current or chronic history within the previous 6 months of gastrointestinal symptoms including abdominal pain or discomfort, nausea, vomiting, bloating, diarrhea or constipation
* History of asthma or chronic respiratory symptoms
* History of allergic rhinitis or chronic sinusitis
* History of allergic reactions attributed to food

Primary outcomes:
measure: measure specific IgE, IgG total, IgG subclass 4, skin prick tests and atopy patch tests to milk, egg, soy, corn, peanut and wheat
timeFrame: 48 hrs and 72 hrs after patch placement
Secondary outcomes:
measure: Determine T-lymphocytes, eosinophils and mast cell densities on duodenal biopsy samples demonstrating eosinophilia
timeFrame: collected at time of biopsy, patient group only
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Children's Mercy Hospital and Clinics
state: Missouri
Study officials:
affiliation: The Children's Mercy Hospital and Clinics
name: Nancy A Neilan, MT (ASCP)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Neilan NA, Dowling PJ, Taylor DL, Ryan P, Schurman JV, Friesen CA. Useful biomarkers in pediatric eosinophilic duodenitis and their existence: a case-control, single-blind, observational pilot study. J Pediatr Gastroenterol Nutr. 2010 Apr;50(4):377-84. doi: 10.1097/MPG.0b013e3181c2c28a.