Study to Identify Non-Invasive Markers of Gastrointestinal Allergy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Children's Hospital Boston.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
TechLab, Incorporate
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00272818
First received: January 4, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

The incidence of gastrointestinal allergy is on the rise and can be manifest in a number of different clinical presentations. The goal of this study is to evaluate the measurement of CD23, a protein that can be identified stool, urine, and blood, as a non-invasive marker for use in the diagnosis and interval assessment of patients with known or suspected gastrointerstianl allergy.

Eosinophilic esophagitis (EE) is a disorder typically found in school-age and adolescent children, and is more prevalent in male patients. Patients with EE typically present with symptoms of heartburn or difficulties swallowing. Blood and x-ray studies may be normal or display non-specific findings. The diagnosis of EE rests on a combination of clinical symptoms, and the results of endoscopic and histologic studies. There is currently no biochemical marker that can be used to monitor disease course in these patients.

Cow milk protein intolerance (CMPI) is an allergic process affecting the distal gastrointestinal tract in infants. As such, it often presents as diarrhea without or without the presence of gross rectal bleeding in infants ranging in age from birth to 6 months of age. Children display symptoms of abdominal disress including emesis, cramping, colic, or feeding difficulties. The diagnosis is based on an appropriate clinical history and supporting physical exam (typically normal). Treatment involves removal of the offending dietary antigens which include cow or soy milk protein Eosinophilic crypt abscesses, or collections of eosinophils within the intestine can also be seen.

CD23 is a protein that can be found on allergy-type white blood cells (eosinophils), as well as on the cells that line the gastrointestinal tract. Previous studies have reported increased levels of CD23 in infants with cow's milk allergy. CD23 is also elevated in infants and children with allergic disease. Levels of CD23 appears to fall in conjunction with therapy.


Condition Phase
Esophagitis
Colitis
Phase 1

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Non Invasive Markers in the Diagnosis and Interval Assessment of Children and Adults With Known or Suspected Allergic Disease

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Estimated Enrollment: 110
Study Start Date: September 2004
Estimated Study Completion Date: December 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Known or suspected cow milk protein intolerance Known or suspected eosinophilic esophagitis

Exclusion Criteria:

None

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272818

Contacts
Contact: Paul A. Rufo, MD, MMSc 617-355-6058 paul.rufo@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Paul A. Rufo, MD, MMSc    617-355-6058    paul.rufo@childrens.harvard.edu   
Principal Investigator: Paul A. Rufo, MD, MMSc         
Sponsors and Collaborators
Children's Hospital Boston
TechLab, Incorporate
Investigators
Principal Investigator: Paul A. Rufo, MD, MMSc Children's Hospital Boston
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00272818     History of Changes
Other Study ID Numbers: 04-07-042
Study First Received: January 4, 2006
Last Updated: January 4, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Colitis
Esophagitis
CD23

Additional relevant MeSH terms:
Colitis
Esophagitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Esophageal Diseases

ClinicalTrials.gov processed this record on April 17, 2014