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Evaluation of Food Hypersensitivity in Children/Adolescents With Functional Dyspepsia

Primary Purpose

Dyspepsia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
in vitro and in vivo allergy testing
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dyspepsia focused on measuring abdominal, stomach, dyspepsia, food allergy

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Mercy Hospital and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

measure specific IgE, IgG total, IgG subclass 4, skin prick tests and atopy patch tests to milk, egg, soy, corn, peanut and wheat

Secondary Outcome Measures

Determine T-lymphocytes, eosinophils and mast cell densities on duodenal biopsy samples demonstrating eosinophilia

Full Information

First Posted
May 18, 2006
Last Updated
October 6, 2008
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT00328679
Brief Title
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

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
abdominal, stomach, dyspepsia, food allergy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
in vitro and in vivo allergy testing
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Determine T-lymphocytes, eosinophils and mast cell densities on duodenal biopsy samples demonstrating eosinophilia
Time Frame
collected at time of biopsy, patient group only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy A Neilan, MT (ASCP)
Organizational Affiliation
The Children's Mercy Hospital and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Mercy Hospital and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20216101
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.
Results Reference
derived

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Evaluation of Food Hypersensitivity in Children/Adolescents With Functional Dyspepsia

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