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Study to Identify Non-Invasive Markers of Gastrointestinal Allergy

This study has been completed.
TechLab, Incorporate
Information provided by (Responsible Party):
Paul Rufo, Children's Hospital Boston Identifier:
First received: January 4, 2006
Last updated: January 26, 2016
Last verified: January 2016

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
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 Boston Children’s Hospital:

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


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

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00272818

United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
TechLab, Incorporate
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 Identifier: NCT00272818     History of Changes
Other Study ID Numbers: 04-07-042 
Study First Received: January 4, 2006
Last Updated: January 26, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Children’s Hospital:

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Esophageal Diseases processed this record on October 28, 2016