Active clinical trials for "Peanut Hypersensitivity"

Peanut allergy is the most common cause of severe allergic reactions to food. Onset is common in childhood, but in contrast to other food allergies such as cow's milk and egg, peanut allergy tends to persist into adulthood. It is associated with a significant impact on quality of life, both for the affected individual and their family. There is no current cure for peanut allergy. Oral peanut immunotherapy (OIT) using defatted, roasted peanut flour has been demonstrated to offer potential in this regard, but is associated with significant and frequent reactions and can cause life-threatening allergic symptoms. The investigators have previously demonstrated that the processing of peanuts through boiling results in a relatively hypoallergenic product due to the loss of key allergenic components from peanut into the water. This has been tested in a recently-completed Phase 2b/3 trial (The BOPI Study, Clinicaltrials.gov NCT02149719; HRA reference 15/LO/0287): 47 children/ young people with peanut allergy confirmed at double-blind, placebo-controlled food challenge (DBPCFC) were randomised (2:1) to receive either oral immunotherapy (updosing using boiled peanut for ~6 months, followed by maintenance with roasted peanut) or standard treatment (allergen avoidance). Participants underwent repeat DBPCFC at 12 months to assess response, following which peanut OIT was stopped and sustained unresponsiveness assessed after 4 weeks (4SU). 24/32 participants (100% per protocol) achieved the primary outcome of desensitisation to >1.44g peanut protein (approximately 6-8 peanuts, p<0.0001); of those 14 tolerated >4.4g peanut protein. 13/24 participants achieved 4SU. There was no significant change in threshold in the control group (p>0.05). Boiled peanut OIT had a favourable safety profile, with under 2% of doses associated with gastrointestinal symptoms. The BOPI-2 study is a non-inferiority study to demonstrate that boiled peanut is at least as effective as peanut flour in treating children with peanut allergy. The study will compare the rate of adverse events and other safety outcomes between these two interventions, and assess the immunological mechanisms involved, a secondary aim being to develop clinically-useful predictors for identifying individuals likely to undergo successful desensitisation.

This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab.

iREACH is a five-year NIH funded study aimed at assessing and improving pediatric clinician adherence to the 2017 NIAID Prevention of Peanut Allergy (PPA) Guidelines. iREACH has been developed as an electronic health record (EHR) integrated Clinical Decision Support (CDS) tool together with educational modules on the PPA guidelines to assist clinicians in implementing the 2017 NIAID PPA Guidelines. A practice-based, two-arm, cluster-randomized clinical trial will evaluate the effectiveness of iREACH in increasing pediatric clinician adherence to the PPA Guidelines and explore the end-goal of reducing peanut allergy incidence by age 2.5 years in the intervention vs control group. This study has the potential to: 1) provide evidence regarding the effectiveness of iREACH in promoting clinical processes and outcomes related to the PPA Guidelines, 2) provide important insight about practice-based implementation of PPA Guidelines by pediatric clinicians, allergists and caregivers, and 3) facilitate rapid, widespread implementation of PPA Guidelines and reduce peanut allergy incidence across the US.

The primary objective of this study is to determine whether allowing ingestion of sub-threshold amounts of peanut in those with a high threshold (tolerate at least 143 mg peanut protein on supervised double-blind, placebo-controlled oral food challenge [DBPCFC]) will be associated with attaining even higher thresholds over time in children with high threshold peanut allergy compared to those avoiding peanut. The secondary clinical objectives include assessing the development of sustained unresponsiveness (SU, a surrogate term for tolerance without daily ingestion), effects on quality of life, and safety compared to those avoiding peanut. Additionally, this study will phenotype the allergic response to peanut based on threshold and response to exposure. Mechanistic study objectives will determine the immune and molecular basis of the high threshold endotype, identify predictors of response to exposure, and determine mechanisms and biomarkers of remission.

this study evaluates whether tolerance to peanuts and tree nuts can be induced in patients through a process of oral immunotherapy. Participants will be randomized into groups receiving oral immunotherapy and a control group that will receive no intervention

At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe. However we know that accidental exposure is common. Researchers have begun to look at the effectiveness of 'oral immunotherapy' as a treatment for food allergy but results have been mixed. This study is a randomized controlled trial to evaluate the effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with Placebo. Children will take increasing doses of peanut protein and a set amount of probiotic until a total of 18 months treatment is completed. Children will be tested for peanut allergy at the start of the study, at the end of PPOIT treatment T1 (18 months) and T2 (8 weeks) and T3 (1year) after treatment.

Open label study with peanut oral immunotherapy (OIT). Peanut allergic children aged 1-3 years of age will be randomized 2:1 to: Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 285 mg daily oral peanut protein or Control group with peanut allergic children who do not undergo OIT. In addition, a group of healthy children without allergic diseases will be included in the study. The primary outcome is tolerance to at least 750 mg peanut protein at a challenge after 3 years and sustained unresponsiveness (i.e. tolerance) to 750 mg peanut protein after 3 years of OIT followed by 4 weeks of avoidance. Efficacy and safety will be compared between group 1 and 2. Group 3 is a control group for analyses of immunological markers.

Prospective Phase 1 clinical trial providing proof of concept data on boiled peanut oral immunotherapy (OIT) for the treatment of peanut allergy in children. The investigators hypothesize that the proportion of subjects successfully desensitized with boiled peanut OIT is greater than the theoretical placebo rate of 20%.

This pilot study is will examine the pathways involved in allergic response, primarily in food allergy; specifically peanut allergy. We will also study non-allergic donors as well as patients with atopic disorders, primarily as control subjects. We believe that this study will lead to discovery of significant pathways involved in the allergic pathway that can be explored in more detail during follow-up studies in order to address mechanistic questions that cannot be answered in a pilot trial. We believe that such a pilot study represents the ideal approach to identify effective therapeutic interventions and to simultaneously better understand the underlying mechanistic properties involved in the allergy cascade. We think that this study forms the basis for a novel avenue of research into the pathogenesis of allergic pathways, a disease that is still associated with significant morbidity and mortality.

The aim of the study is to assess the prevalence of peanut, tree nuts, and sesame allergy in Polish children at high risk of food allergy. Additionally, the timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population will be assessed.