Multi Immunotherapy to Test Tolerance and Xolair
Food AllergyThis is a phase 2 randomized, double-blind, placebo controlled study which will be conducted at multiple centers in the U.S. All subjects will receive oral immunotherapy for their specific food allergies (limited to 5 of those food allergens in Investigational New Drug (IND) 14831). All subjects will receive Omalizumab for 16 weeks. The subject's allergens will be introduced in a rush desensitization day at week 8. Subjects will return to clinic to escalate the dose of their allergens until 2,000mg protein of each allergen is reached Subjects will return to clinic for a DBPCFC to each allergen at week 30. If subjects are nonreactive to 2 or more allergens during their DBPCFC at week 30 they will be randomized to one of three double blinded arms: Arm A- continue with current dose (2000 mg each food allergen protein), Arm B-300 mg of each food allergen protein, Arm C-placebo (avoiding food allergen protein), their current dose. All subjects will return to clinic for a DBPCFC to each allergen at week 36. The final challenge of week 36 will be the final end of study visit. Safety is a paramount concern in the study design and will be monitored carefully throughout the study. Study subjects and their parents/guardians will receive extensive education on food allergy reactions and medication use.
Multi OIT to Test Immune Markers After Minimum Maintenance Dose
Food AllergyFew studies have been conducted to optimize safety of multiple food allergen oral immunotherapy (OIT) in conjunction with Omalizumab as well as to identify the immunological mechanism(s) underlying any long-lasting effects of OIT. To address these issues in the field of food allergy research, we have designed this study to test whether: 1) Omalizumab improves the safety of multiple food allergen OIT in subjects with multi food allergies, 2) Omalizumab treatment with multiple food allergen OIT is associated with the ability to use a lower maintenance dose of each food allergens in the OIT regimen, particularly in younger subjects with food allergies.
A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily...
Food AllergyPrimary Objective: To assess tolerability and safety of SAR439794 [peanut extract (PE) sublingual immunotherapy (SLIT) adjuvanted with Glucopyranosyl Lipid A (GLA)] after repeated sublingual (SL) daily administration in peanut allergic adult and adolescent patients. Secondary Objective: To assess pharmacodynamics of SAR439794 after repeated SL daily administration in peanut allergic adult and adolescent patients.
A Study of Sublingual Immunotherapy in Peanut-allergic Children
Food HypersensitivityThe specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children.
Treatment of Autistic Children Using NAET Procedures
AutismFood AllergiesPurpose of this study is to determine whether NAET procedures are effective in the treatment of children with allergy-related autism spectrum disorders in restoring their verbal and nonverbal communication. Hypothesis: Children in the experimental group will show a significant improvement over the control group in verbal and nonverbal communication as most food allergen groups, environmental allergen groups, childhood immunizations, and some other relevant allergenic substances are desensitized in a systematic way using NAET® procedures within the specified period of study.
Oral Immunotherapy for Childhood Egg Allergy
HypersensitivityImmediate Hypersensitivity1 moreThe purpose of this study is to determine if oral immunotherapy (OIT) will desensitize a child with an allergy to egg and eventually lead to the development of tolerance to egg.
Effects of Montelukast in Asthmatic Children With and Without Food Allergy
Bronchial AsthmaFood Allergy1 moreTo search the effects of montelukast on the airway inflammation including FEV1%, FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge tests, the leukotriene levels in the exhaled breath condensate in asthmatic children with and without food allergy aged 6-18 years old. To define the patient groups with good response to montelukast and to define the parameters which predict the good response.
Online Mindfulness-based Cognitive Therapy for Parents of Children With Food Allergies
The Quality of Life of Parents of Children With Food AllergyThis study aims to conduct an initial evaluation of adapted, live online, mindfulness-based cognitive therapy for parents and carers of children with food allergies (MBCT-PCCFA).
Promoting Tolerance to Peanut in High-Risk Children
EczemaEgg Allergy1 moreThis study will evaluate whether early exposure to peanuts promotes tolerance and provides protection from developing peanut allergy in children who are allergic to eggs or who have severe eczema. This study has been continued into the ITN049AD (LEAP-On) Study (NCT01366846).
Detection of Metabolite Biomarkers for the Early Diagnosis and Prognosis of Cow's Milk Allergy in...
Cow Milk AllergyFood AllergyIn this study, fecal and urine samples will be collected from children diagnosed with : IgE mediated cow's milk allergy, suspected of a cow's milk allergy, but with negative diagnosis IgE mediated food allergy other than cow's milk healthy brothers and sisters of the first three groups A subset of patients with IgE-mediated cow's milk allergy will be asked to provide a urine and fecal sample yearly for prognostic purposes. The samples will be analyzed using a technique called metabolomics to identify biomarker candidates with diagnostic and/or prognostic potential. Additionally, microbiome analysis will be performed to map the microbiome of all groups.