Clinical Trials Logo

Clinical Trial 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 t...


Clinical Trial Description

Eosinophilic gastroenteritis (EG) is characterized by eosinophilic infiltration of the bowel wall, gastrointestinal symptoms, and in more than 50% of patients, peripheral eosinophilia. Approximately one half of EG patients have multiple food allergies and/or elevated immunoglobulin E (IgE), suggesting an allergic etiology. The purpose of this study is to evaluate the safety and efficacy of humanized monoclonal anti-IgE antibody, omalizumab (Xolair (Registered Trademark)), in eosinophilic gastroenteritis. Omalizumab is approved for use in asthma and is dosed subcutaneously based on serum total IgE level and body weight, with a maximum dose of 375 mg every 2 weeks. Subjects with EG, and either food hypersensitivity or environmental allergies will be admitted to the Clinical Center. All subjects will undergo a thorough clinical evaluation, including endoscopy. The primary endpoints will be the evaluation of safety of omalizumab and its efficacy in reducing peripheral blood absolute eosinophil count. In addition, the following secondary endpoints will be studied: symptom scores, study drug pharmacodynamics, and tissue eosinophilia. Blood cells and serum will be collected and evaluated in the laboratory to address issues related to the immunopathogenesis and treatment of EG. This study will provide a better understanding of inflammatory and allergy mediators in the pathogenesis of EG and may provide a potential therapy for EG. Following subcutaneous administration of the initial dose of omalizumab (maximum 375 mg), subjects will be followed as inpatients for a minimum of 24 hours to monitor for adverse effects. Subsequent doses will be administered biweekly for a total of 8 doses. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00084097
Study type Interventional
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase Phase 2
Start date June 2, 2004
Completion date February 5, 2007

See also
  Status Clinical Trial Phase
Completed NCT01168401 - Bivalent Norovirus Vaccine Study Phase 1
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Completed NCT02473887 - Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting Phase 1
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Not yet recruiting NCT01671137 - Probiotic for the Prevention of Functional Disorders in Childhood N/A
Completed NCT01917461 - Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections N/A
Withdrawn NCT00691275 - Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration N/A
Recruiting NCT06025695 - Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks Phase 3
Completed NCT04463082 - Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound N/A
Completed NCT02497417 - A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients N/A
Active, not recruiting NCT03000296 - Autologous Unselected Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease N/A
Completed NCT01236066 - Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia N/A
Completed NCT01225042 - The Effect of Probiotics on E. Coli Gastroenteritis N/A
Recruiting NCT00987519 - Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age N/A
Terminated NCT01357174 - ROTATEQâ„¢ Post-Marketing Surveillance in the Philippines N/A
Completed NCT01033799 - Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers N/A
Recruiting NCT01363726 - Surveillance of Rotavirus Gastroenteritis in Children <5 Years N/A
Completed NCT00130832 - Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED) Phase 3
Terminated NCT02568189 - Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration N/A
Terminated NCT02165813 - Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children Phase 2/Phase 3