Study to Identify Non-Invasive Markers of Gastrointestinal Allergy
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Longitudinal Time Perspective: Prospective |
| Official Title: | Non Invasive Markers in the Diagnosis and Interval Assessment of Children and Adults With Known or Suspected Allergic Disease |
| 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 |
Inclusion Criteria:
Known or suspected cow milk protein intolerance Known or suspected eosinophilic esophagitis
Exclusion Criteria:
None
Contacts and Locations| Contact: Paul A. Rufo, MD, MMSc | 617-355-6058 | paul.rufo@childrens.harvard.edu |
| 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 | |
| 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 May 22, 2013