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Study to Identify Non-Invasive Markers of Gastrointestinal Allergy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00272818
First Posted: January 9, 2006
Last Update Posted: January 27, 2016
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.
Collaborator:
TechLab, Incorporate
Information provided by (Responsible Party):
Paul Rufo, Children's Hospital Boston
  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: Case-Only
Time Perspective: Prospective
Official Title: Non Invasive Markers in the Diagnosis and Interval Assessment of Children and Adults With Known or Suspected Allergic Disease

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

Enrollment: 110
Study Start Date: September 2004
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with known or suspected GI allergy.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00272818


Locations
United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
TechLab, Incorporate
Investigators
Principal Investigator: Paul A. Rufo, MD, MMSc Boston Children’s Hospital
  More Information

Responsible Party: Paul Rufo, Assistant Professor of Pediatrics, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00272818     History of Changes
Other Study ID Numbers: 04-07-042
First Submitted: January 4, 2006
First Posted: January 9, 2006
Last Update Posted: January 27, 2016
Last Verified: January 2016

Keywords provided by Paul Rufo, 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


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