Protocol Number: 04-I-0176

Title:

Pilot Study of Omalizumab in Eosinophilic Gastroenteritis

Number:

04-I-0176

Summary:

This study will evaluate the safety and usefulness of omalizumab (anti-IgE, Xolair) in reducing eosinophil counts and improving symptoms in patients with eosinophilic gastroenteritis (EG). EG is a disorder of unknown cause in which eosinophils, a type of white blood cell, are increased in the blood and gut tissue. Patients with EG have symptoms like stomach pain, bloating, and vomiting. About 50 percent of EG patients have food or environmental allergies, which may play a role in EG. Some patients with EG improve significantly on diets avoiding foods to which they are allergic. Immunoglobulin E (IgE) is an antibody that plays an important role in initiating allergic reactions. Omalizumab is a monoclonal antibody directed against IgE. The Food and Drug Administration approved omalizumab in 2003 for treating patients 12 years of age and older with allergic asthma.

Patients between 12 and 76 years of age with eosinophilic gastroenteritis who have a blood eosinophil count of 500 or more and who have a food allergy or allergy to an inhaled allergen may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests.

Participants undergo the following procedures:

- Leukapheresis. This procedure is done to collect quantities of white blood cells to study the effects of omalizumab on eosinophils and other immune substances. Blood flows from a needle placed in an arm vein through a catheter (plastic tube) into a machine that separates the blood into its components by centrifugation (spinning). Some of the white cells are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body through a needle in the other arm.

- Skin testing. Participants are tested for allergies to specific substances. A small amount of various allergens (substances that cause allergies) are placed on the subject's arm. The skin is pricked at the sites of the allergens and the skin reaction after several minutes is observed.

- Upper and lower endoscopy. One or both of these procedures is done, depending on the part of the gastrointestinal tract that is involved, to examine the tract. If both procedures are done, they are performed at the same time. For the upper endoscopy, the subject's throat is sprayed with a numbing medicine and a long, flexible tube is passed through the esophagus, stomach and small intestine. For the lower endoscopy, the tube is passed through the rectum into the large intestine. Subjects are given a medication to cause relaxation through a vein before the procedure. Biopsies (removal of small amounts of tissue) are done during both endoscopies.

- Omalizumab therapy. Omalizumab is given as an injection under the skin. Following the first injection, subjects stay in the NIH Clinical Center hospital for 24 hours for safety monitoring. The remaining doses are scheduled as outpatient visits every 2 weeks after the first dose for a total of four doses. Two weeks after the last dose, patients are admitted to the Clinical Center for 2 to 3 days for repeat endoscopy, leukapheresis, skin testing, and physical examination. Additional follow-up visits are scheduled at 14 and 22 weeks after the first dose of drug for a physical examination and blood tests. If the subject's blood eosinophil count has not returned to its original baseline level by the 22 weeks visit, another visit will be scheduled at week 30.

- Symptoms scores and medication use cards. Participants must complete a symptoms score card for 3 weeks before starting omalizumab treatment. They continue record symptoms scores and medication use throughout the study. The cards are collected periodically at follow-up visits.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Allergy

IgE

Eosinophil

Monoclonal Antibody

Recruitment Keyword(s):

Eosinophilic Gastroenteritis

EG

Condition(s):

Gastroenteritis

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Drug: Omalizumab

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Lee M, Hodges WG, Huggins TL, Lee EL. Eosinophilic gastroenteritis. South Med J. 1996 Feb;89(2):189-94.

Kelly KJ. Eosinophilic gastroenteritis. J Pediatr Gastroenterol Nutr. 2000;30 Suppl:S28-35. Review.

Park HS, Kim HS, Jang HJ. Eosinophilic gastroenteritis associated with food allergy and bronchial asthma. J Korean Med Sci. 1995 Jun;10(3):216-9.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008