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NCT00272818 · ClinicalTrials.gov registry record

Study to Identify Non-Invasive Markers of Gastrointestinal Allergy

A clinical trial, sponsored by Boston Children's Hospital.

Completed
Registry status
110
Enrollment target

NCT00272818 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 110 participants.

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The verdict

NCT00272818 has completed, sponsored by Boston Children's Hospital.

COMPLETED
Registry status
110 participants
Enrollment target

Study Summary

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.

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2004-09
Est. Completion 2008-12

Sponsor

Boston Children's Hospital

462 total trials

What the Registry Record Tells You About NCT00272818

The ClinicalTrials.gov registry entry for NCT00272818 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00272818 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00272818 about?

NCT00272818 is a clinical study titled "Study to Identify Non-Invasive Markers of Gastrointestinal Allergy". 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...

What is the current status of trial NCT00272818?

This trial is currently completed. The enrollment target is 110 participants. The study started on 2004-09. Estimated completion is 2008-12.

Who is sponsoring clinical trial NCT00272818?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.