Evaluation of Food Hypersensitivity in Children/Adolescents With Functional Dyspepsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00328679
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : October 8, 2008
Information provided by:
Children's Mercy Hospital Kansas City

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Device: in vitro and in vivo allergy testing Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Food-Specific IgE, IgG, IgG4, Skin Prick Testing and Atopy Patch Testing in Children/Adolescents With Functional Dyspepsia: A Pilot Study
Study Start Date : June 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Device: in vitro and in vivo allergy testing
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.

Primary Outcome Measures :
  1. measure specific IgE, IgG total, IgG subclass 4, skin prick tests and atopy patch tests to milk, egg, soy, corn, peanut and wheat [ Time Frame: 48 hrs and 72 hrs after patch placement ]

Secondary Outcome Measures :
  1. Determine T-lymphocytes, eosinophils and mast cell densities on duodenal biopsy samples demonstrating eosinophilia [ Time Frame: collected at time of biopsy, patient group only ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00328679

United States, Missouri
The Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Principal Investigator: Nancy A Neilan, MT (ASCP) The Children's Mercy Hospital and Clinics

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Nancy Neilan, MT (ASCP)/ Research Coordinator, Children's Mercy Hospitals and Clinics Identifier: NCT00328679     History of Changes
Other Study ID Numbers: 0604-068
First Posted: May 22, 2006    Key Record Dates
Last Update Posted: October 8, 2008
Last Verified: October 2008

Keywords provided by Children's Mercy Hospital Kansas City:
food allergy

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms