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OIT and Xolair® (Omalizumab) in Cow's Milk Allergy

2014-07-23 21:08:33 | BioPortfolio

Summary

Food allergy affects up to 4% of the U.S. population and is most common in young children. Milk allergy is the most common cause of food allergy in infants and young children, and usually develops in the first year of life. There is no treatment for food allergy and the current standard of care for milk-allergic individuals is the avoidance of milk-containing products. Research is underway to identify potential therapeutic strategies to reduce or eliminate the adverse effects experienced by milk-allergic individuals when they consume milk-containing products.

Several studies have suggested that milk-allergic children who receive milk protein oral immunotherapy (OIT) may become desensitized to milk, resulting in short term protection against accidental ingestion of milk products. However, these children did not develop "tolerance," which is long term protection even after milk immunotherapy is stopped. A potential strategy to induce tolerance to milk uses milk in combination with Xolair® (omalizumab). Xolair consists of anti-IgE molecules that attach to IgE, the major antibody involved in allergic reactions. The goal of this clinical trial is to see whether Xolair® in combination with milk protein OIT is safer and more effective than OIT alone in inducing tolerance to milk and milk products. Participants will be administered a double blind, placebo controlled milk challenge at various time points in the study. If desensitization is achieved participants will be tested for tolerance at a certain time point after stopping treatment.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Milk Allergy

Intervention

Xolair® (omalizumab) placebo/milk OIT, Xolair® (omalizumab)/milk OIT

Location

Johns Hopkins University School of Medicine
Baltimore
Maryland
United States
21287

Status

Not yet recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:33-0400

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PubMed Articles [1742 Associated PubMed Articles listed on BioPortfolio]

TGF-β activity in cow milk and fermented milk products: An in vitro bioassay with oral fibroblasts.

Milk is a rich source of transforming growth factor (TGF)-β which supports intestinal mucosal homeostasis of infants. Milk may also have beneficial effects on the integrity of the oral cavity, its be...

The distribution of essential, trace, and non-essential minerals in weanling male rats fed sheep or cow milk.

The aim of the study was to determine the effects of sheep milk consumption in comparison to cow milk on the mineral distribution in the soft organs and serum in a growing animal model system. As the ...

Technical note: Development and validation of an HPLC method for the quantification of tocopherols in different types of commercial cow milk.

In the present study, a methanol-fluorescence-based HPLC method was validated for its use to quantify α-tocopherol and γ-tocopherol in raw milk, whole UHT milk, partially skimmed UHT milk, whole pas...

Determination of milk/plasma ratio and milk and plasma pharmacokinetics of amoxicillin after intramuscular administration in lactating cows.

This study was conducted to determine the passage ratio of amoxicillin into milk and its pharmacokinetics in milk and plasma after intramuscular administration. Five healthy dairy cows (Holstein, weig...

A critical review of human milk sharing using an intersectional feminist framework: Implications for practice.

Driven by a growing body of research demonstrating the health benefits of human milk over substitute feeding preparations, the demand for human milk donations in North America is rapidly increasing. I...

Medical and Biotech [MESH] Definitions

Allergic reaction to milk (usually cow's milk) or milk products. MILK HYPERSENSITIVITY should be differentiated from LACTOSE INTOLERANCE, an intolerance to milk as a result of congenital deficiency of lactase.

The processes of milk secretion by the maternal MAMMARY GLANDS after PARTURITION. The proliferation of the mammary glandular tissue, milk synthesis, and milk expulsion or let down are regulated by the interactions of several hormones including ESTRADIOL; PROGESTERONE; PROLACTIN; and OXYTOCIN.

Expulsion of milk from the mammary alveolar lumen, which is surrounded by a layer of milk-secreting EPITHELIAL CELLS and a network of myoepithelial cells. Contraction of the myoepithelial cells is regulated by neuroendocrine signals.

The major protein constituents of milk are CASEINS and whey proteins such as LACTALBUMIN and LACTOGLOBULINS. IMMUNOGLOBULINS occur in high concentrations in COLOSTRUM and in relatively lower concentrations in milk. (Singleton and Sainsbury, Dictionary of Microbiology and Molecular Biology, 2d ed, p554)

Centers for acquiring, storing, and distributing human milk.

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