NCT00328679

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

October 8, 2008

Status Verified

October 1, 2008

Enrollment Period

2.3 years

First QC Date

May 18, 2006

Last Update Submit

October 6, 2008

Conditions

Dyspepsia

Keywords

abdominalstomachdyspepsiafood allergy

Outcome Measures

Primary Outcomes (1)

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

    48 hrs and 72 hrs after patch placement

Secondary Outcomes (1)

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

    collected at time of biopsy, patient group only

Study Arms (1)

A

EXPERIMENTAL
Device: in vitro and in vivo allergy testing

Interventions

in vitro and in vivo allergy testingDEVICE

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.

A

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

  • 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.

    PMID: 20216101DERIVED

MeSH Terms

Conditions

DyspepsiaFood Hypersensitivity

Interventions

In Vitro Techniques

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Nancy A Neilan, MT (ASCP)

    The Children's Mercy Hospital and Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2006

First Posted

May 22, 2006

Study Start

June 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

October 8, 2008

Record last verified: 2008-10

Locations

US(1)