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Allergy clinical trials

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NCT ID: NCT03872219 Not yet recruiting - Allergic Rhinitis Clinical Trials

Biodiversity Intervention and Atopic Sensitization

PREVALL
Start date: March 25, 2019
Phase: N/A
Study type: Interventional

Children will receive biodiversity intervention or placebo. The proof of concept trial is double blind. Intervention will start at the age of 2 months and last 10 months. Children will be randomized to arms. IgE sensitization is the primary outcome.

NCT ID: NCT03449836 Not yet recruiting - Allergy Clinical Trials

Effects of the Direct Interaction Between Streptococcus Salivarius 24SMBc and Streptococcus Oralis 89a and the Respiratory Epithelium in Children

Start date: March 1, 2018
Phase: Phase 3
Study type: Interventional

Allergic rhinoconjunctivitis is a pathology of the nasal and conjunctival mucosa induced by Immunoglobulin E (IgE) mediated inflammation following allergic exposure. This condition represents a global health problem that affects 5 to 20% of the population. As with all allergic diseases, its prevalence in pediatric age has increased over the last 30 years, as shown by the results of the international epidemiological study International Study of Asthma and Allergies in Childhood (ISAAC) which shows that the overall prevalence is 8.5 % in children aged 6-7 and 14.6% in children aged 13-14. In Italy, on average, the prevalence stands at 17.6% in the 6-7 year age range and 31.3% in the 13-14 age range, demonstrating a growing trend. The allergic rhinoconjunctivitis undiagnosed and / or not treated properly can negatively affect the school activities and in general the quality of life of children and their parents, as well as having important socio-economic repercussions in terms of medical expenses, school absences and days of work lost by parents. Furthermore, the lack of therapeutic intervention can lead to an increased risk of complications in the medium and long term. Recent advances in the understanding of the mechanisms underlying the inflammation of the airways have led to an improvement of the therapeutic strategies for the management of allergic rhinoconjunctivitis: the four cornerstones of the approach to this pathology promoted by the European Academy of Allergy and Clinical Immunology (EAACI) include allergen removal, patient education, pharmacotherapy and specific immunotherapy. However, there is discordant evidence to support their efficacy in reducing the symptomatology of allergic rhinoconjunctivitis, with the need to resort to the invasive surgical approach in several cases. Therefore, the use of probiotics, defined as "live micro-organisms which, when administered in adequate quantities, confer an advantage for the organism" can be useful. The mechanisms by which probiotics or their components, for example DNA, proteins and peptides, exert such beneficial effects concern the regulation of the immune system, the antagonist action against potentially pathogenic microorganisms and the quantitative and qualitative modulation of the intestinal microbiota. In fact, recent clinical studies have demonstrated the protective effect of infections of the high respiratory tract in adults and recurrent average otitis in pediatric age of the Streptococcus salivarius 24SMBc and Streptococcus oralis 89a strains administered through nasal spray. These well-characterized probiotics were safe, tolerated and able to positively modulate the composition of the respiratory epithelial microbiota and the function of the immune system.

NCT ID: NCT02720809 Not yet recruiting - Clinical trials for Cardiovascular Disease

Health2016: Monitoring Chronic Disease and Risk Factors in the General Population

Start date: May 2016
Phase: N/A
Study type: Observational

Health2016 is a general population cross-sectional study aimed at completing af monitoring program for monitoring chronic disease and risk factors in the period 2006 to 2016. Similar studies have been performed in 2006, 2010, and 2013.

NCT ID: NCT01923519 Not yet recruiting - Allergy Clinical Trials

Study of Genic Expression Profiles of the Epithelium of the Nose and Bronchi in Healthy and Allergic Subjects

GENEBRO
Start date: August 2013
Phase: N/A
Study type: Interventional

The respiratory epithelium plays a leading role in the development of allergic respiratory disease with barrier function alteration, its repair mechanisms, of anti-viral fight and the ability to induce by itself Th2 responses. The majority of allergic asthmatic patients have reached concomitant ENT: the concept of "one airway, one disease." Access to this material of epithelial study in the different phenotypes of the disease appears to be crucial. Nasal and bronchial epithelial tissues reveal essential differences in particular related to their environment (remodeling less intense and a lower sensitivity to the virus in the nose), but they nevertheless share many common cellular characteristics.

NCT ID: NCT01816542 Not yet recruiting - Allergy Clinical Trials

Evaluation of Irritancy/Allergic Sensitivity to Natural Personal-care Products by Patch Tests

Start date: June 2013
Phase: N/A
Study type: Interventional

The purpose of the study is to determine if any of Mother's Choice' all-natural personal-care products cause either irritation or allergic reaction when applied to both normal or sensitive skin. Each product will be tested on the skin using patch tests.

NCT ID: NCT01413256 Not yet recruiting - Allergy Clinical Trials

Allergenic Effect of Ambrosia in Israel

Start date: October 2011
Phase: N/A
Study type: Observational

Background: Respiratory allergic reaction causes great suffering to millions of people worldwide. One of the most known allergen- is the pollen from vegetation, ragweed. Genus Ambrosia Ambrosia belonged to the complex ragweed flowers are pollinated by the wind and the plant's male flowers produce large quantities of small grains of pollen and airborne over long distances and those causes allergic reactions. The plant blooms between June and October, creating a second wave after wave of allergy caused by spring blossoms. This plant originated in North America has invaded many areas in Europe and in recent years, taking over large areas in Israel, Hula Valley and northern Acre Emek Hefer for a pen and layers to the south. After ragweed plants are based in particular they spread quickly and invade agricultural fields and significantly reduce the crop. High allergenic ragweed is a health hazard to humans. Ragweed plant investigated many aspects of North America and Europe in recent decades and extensive literature on ambrosia, but this is the first time ragweed study focuses on Israel. Working hypothesis and aims: Goal of this study is to identify the existence and nature of the sensitivity distribution of ragweed in Israel. Importance of research: A. Ragweed allergen testing and comparing the effect of exposure to plants on the sensitivity of the allergic Israeli patients B. The inclusion of ragweed allergen in the diagnostic and therapeutic panel

NCT ID: NCT01353924 Not yet recruiting - Allergy Clinical Trials

Immune Response of Individuals Vaccinated With Hypoallergenic Derivatives of the Major Birch Pollen Allergen, Bet v 1

Start date: August 2011
Phase: Phase 1
Study type: Interventional

The only disease-modifying treatment for allergic disorders nowadays is allergen-specific immunotherapy (SIT). To induce hyporesponsiveness increasing doses of the disease-eliciting allergens are applied. One major problem of this treatment is, that it has to combat with an already established immune response against the disease-eliciting allergen. To circumvent this problem the investigators want to perform the proof of principle study towards prophylactic treatment. Prophylactic vaccination is used since many years for many infectious diseases. The investigators want to adopt this successful principle for the treatment of type I allergies. For this purpose non-allergic healthy individuals will be immunized with adjuvant-bound hypoallergenic derivatives of the major birch pollen allergen, Bet v 1. As usual for allergen-specific immunotherapy, injections will be applied subcutaneously. Three injections in one-monthly intervals will be given to establish the immune response and a further injection after one year will determine how the vaccine-induced immune response can be boosted. The vaccine will be composed of an equimolar mixture of two adjuvant-bound hypoallergenic derivatives of the major birch pollen allergen, Bet v 1. The first investigational product (IP) designated as Bet v 1aF1 is a protein of 73 amino acid residues and represents the first half (1-73aa) of the Bet v 1 molecule. The second IP, Bet v 1aF2, is a protein of 86 amino acid residues and represents the second half (74-160aa) of Bet v 1. Both proteins are expressed in Escherichia coli. The hypoallergenic derivatives lost their IgE binding capacities by the disruption of the conformational IgE epitopes of the Bet v 1 molecule. In several preclinical and clinical studies it has been shown that the two hypoallergenic fragments, Bet v 1aF1 and Bet v 1aF2 have a strongly reduced allergenic reactivity and almost no sensitization potential, requisite for a prophylactic treatment. In a multi-centre placebo-controlled double blind clinical trial including 124 allergic patients no relevant sensitization against new epitopes could be observed after vaccination of the Alum-bound Bet v 1 derivatives. In contrast, the vaccine induced a strong IgG response in animals as well as in clinical studies. Vaccine-induced antibodies showed protective properties as they could inhibit the binding of allergic patients' IgE. An improvement of clinical symptoms and a reduction of the skin reactivity was correlated with an increase of IgG antibodies and could be shown only in actively treated patients in a multi-centre placebo-controlled double blind clinical trial. The investigational products will be tested in a Phase I clinical trial for prophylactic allergy vaccination in healthy non-allergic subjects. The two IPs will be coupled either to Alum and an equimolar mixture will be injected subcutaneously. The immune responses will be compared to placebo. In total 20 non-allergic healthy male subjects (10 per group) will be included in this clinical trial. For safety precautions the subjects will be monitored by skin prick testing using the two uncoupled IPs and commercial birch pollen extract in short intervals to recognize possible vaccine-induced sensitizations. The primary endpoint of phase I clinical trial is the evolution of Bet v 1-specific and Bet v 1 fragment-specific IgG1-4, IgE and IgM antibody levels in serum and in nasal fluids after vaccination of rBet v 1 derivatives.

NCT ID: NCT01239719 Not yet recruiting - Allergy Clinical Trials

Randomized Study for Effectiveness and Safety Evaluation of Dexamethasone 0.5 mg + Fumarate Clemastine 1 mg Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis

Start date: March 2011
Phase: Phase 3
Study type: Interventional

The aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of allergic dermatitis.

NCT ID: NCT01159379 Not yet recruiting - Allergy Clinical Trials

Safety of Ertapenem in Beta-lactam Allergic Patients.

Start date: January 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess cross-reactivity and tolerability of ertapenem in patients with IgE-mediated allergy to at least one beta-lactam molecule.

NCT ID: NCT00258141 Not yet recruiting - Allergy Clinical Trials

Study With Rupatadine in Mosquito-Bite Allergic Adult Subjects

Start date: n/a
Phase: Phase 4
Study type: Interventional

The study will find out how effective rupatadine is in the treatment of mosquito bite symptoms in adult patients allergic to mosquito bites.