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NCT06256146
Protocols for Oral Immunotherapy (OIT) for the main food allergens have been recently incorporated in clinical practice for food allergies and their clinical benefits have been acknowledged in European and Canadian official guidelines. There has been some reluctance in both clinicians and patients to implement these therapies, primarily because of the risk of allergic reactions during the desensitization process. This study will investigate if protocols using low doses of a food allergen or processed versions of the allergen can be both effective in conferring desensitization while inducing fewer allergic symptoms during the desensitization process.
NCT06923878
The study is aimed at improving the diagnosis of food allergy, specifically allergy to commonly consumed legumes such as peas, lentils, chickpeas or green beans. Patients suspected of allergy to these legumes will be examined using traditional methods of IgE-mediated allergy diagnosing (skin prick test, testing for specific IgE antibodies against food extract), but also by testing for specific IgE antibodies against relevant allergenic molecules of these legumes. The results of performed tests will be compared with the result of the oral food challenge, which is considered to be the gold standard of food allergy diagnosis.
NCT07501325
This study will evaluate whether blood tests that measure IgE antibodies to two shrimp proteins, tropomyosin and hemocyanin, can help diagnose shrimp allergy in children. Children with suspected IgE-mediated shrimp allergy will undergo oral food challenge, skin prick testing, and blood sampling. Oral food challenge results will be used as the reference standard to determine whether these tests can accurately identify true shrimp allergy and help improve diagnosis in clinical practice.
NCT04552522
Oral immunotherapy is effective in desensitized food allergy. Shrimp allergy is increasing in Thailand. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to shrimp, Immunoglobulin G4 and immunoblot analysis in shrimp allergy patients after shrimp oral immunotherapy.
NCT01923519
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.
NCT07412990
Objective of this non-interventional study (NIS) is to collect data on the use of Grassmuno® in routine clinical practice.
NCT07485699
Soy allergies are widespread and are becoming increasingly significant today as people around the world consume more and more soy and soy-containing foods. Soy is used in many products and undergoes various processing steps such as heating, extraction, enzymatic degradation, and preservation. However, it is not yet fully understood how these processing steps affect soy's ability to trigger allergic reactions. The goal of this project is to process soy in various controlled ways and investigate how these methods affect its allergenic potential. First, the effects will be tested in the laboratory (in vitro). Subsequently, the results will be examined in humans using a skin prick test (SPT) to determine how the processed soy affects allergic reactions
NCT06406114
Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.
NCT07484035
This is a prospective, multi-center, randomized, open-label, active-controlled, parallel-group, non-inferiority study. The goal of this clinical trial is to evaluate the clinical efficacy and safety of an extensively hydrolyzed formula (eHF) in treating infants with mild-to-moderate cow's milk protein allergy (CMPA). CMPA is a common condition in babies where the immune system reacts to proteins in cow's milk, causing symptoms affecting the skin (such as eczema or hives), gastrointestinal tract (such as vomiting, diarrhea, or constipation), and respiratory system (such as runny nose or wheezing). The study plans to enroll 124 infants aged 0-5 months who have been diagnosed with mild-to-moderate CMPA by a physician based on established diagnostic criteria. The main questions it aims to answer are: 1. Does this new formula effectively relieve CMPA symptoms? Relief is defined as a reduction in severity from baseline for at least one scored symptom (skin, gastrointestinal, or respiratory) observed during study visits. The overall symptom relief rate at Day 28 will be calculated as: (number of effective cases / total number of cases) × 100%. 2. What medical problems or side effects do infants experience when using this formula? Researchers will compare the new formula (Feihe Extensively Hydrolyzed Formula) to an already approved extensively hydrolyzed formula (a standard treatment for CMPA) to see if the new formula works as well (non-inferiority). Eligible participants will be randomly assigned (like drawing lots) in a 1:1 ratio to either the test group or the control group. The randomization process will be stratified by age: infants aged \>0 to ≤2 months (targeting 40% of participants) and infants aged \>2 to ≤5 months (targeting 60% of participants). A centralized interactive web response system (IWRS) will be used to ensure unbiased assignment. Study Duration and Visits: The study will last approximately 28 days. After the initial screening visit (V0), participants will need to visit the clinic 3 times: * Visit 1 (V1, Day 0, before taking the study product): Baseline assessments * Visit 2 (V2, Day 14 ± 1 day): Follow-up assessments * Visit 3 (V3, Day 28 ± 1 day): Final assessments What Participants Will Do: * Receive study formula: At V1 and V2, researchers will provide enough formula until the next visit. At V2 and V3, parents should return any empty cans. * Undergo medical assessments: At each visit (V1, V2, V3), the doctor will: * Assess atopic dermatitis severity using the SCORAD tool (combining physical examination with parent-reported itching and sleep quality) * Assess nasal and eye symptoms (and asthma symptoms, if applicable) using the VAS * Assess gastrointestinal, skin, and respiratory symptoms using the CoMiSS * At the final visit (V3), evaluate overall treatment effectiveness based on symptom improvement * Have growth measurements taken: At each visit, researchers will measure the infant's weight (in grams), length (in cm), and head circumference (in cm). Growth velocity and Z-scores will be calculated. * Complete parent questionnaires: At each visit, parents will: * Report on the infant's itching and sleep for the SCORAD assessment * Complete the IGSQ to assess gastrointestinal symptoms * Use the BSFS pictures to help describe the infant's stool form * Collect stool samples: Before each visit (V1, V2, V3), parents will collect a small stool sample (about 4-5 grams) using a provided kit. These samples will be tested for routine analysis and occult blood. * Maintain a feeding diary: From V1 to V3, parents will keep a daily diary recording the amount of study formula consumed and any breastfeeding. * Report health events: Inform the study team of any illnesses, discomfort, or medications the infant experiences throughout the study. * Undergo optional bone density testing: At each visit, an ultrasound bone density measurement may be performed at the clinic's discretion.
NCT04828603
The purpose of this study is to strengthen our ability to accurately diagnose allergies and understand cellular, humoral, genetic components and physiological changes in allergic disease
NCT01305161
To assess diagnostic accuracy of flow cytometry applied to the diagnosis of allergy to neuro-muscular blockers and to the determination of the neuro-muscular blocker (NMB) which may be used for an ulterior anaesthesia in case of allergy to one given NMB.
NCT05138757
The purpose of this research is to gather information on the safety and efficacy of using a prebiotic as an adjunctive therapy to peanut oral immunotherapy. The prebiotic is not an FDA approved drug or medication rather a fiber found at local grocery stores.
NCT06765213
The goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants. The main question\[s\] it aims to answer are: * Will major allergens for milk, egg, and peanut be passed on to infants in breast milk? * Will the infants become sensitized to and develop an allergy to the food allergens found in breast milk? * Will early introduction interventions prevent the development of these food allergies? Participants will * provide breast milk sample (s) for testing for food allergens * Infants will be tested for sensitization via skin prick and blood testing * Infants will be challenge with suspected foods to determine allergy and undergo early introduction procedures
NCT07427576
House dust mites are the main source of allergies in indoor environments. They are predominant in coastal areas, with the Canary Islands being the autonomous community with the highest percentage of patients with rhinoconjunctivitis due to sensitisation to these mites (94.7%). Immunotherapy is indicated for the treatment of allergic rhinoconjunctivitis and is capable of altering the natural course of allergic diseases. The aim of the study was to evaluate the efficacy and safety of Clustoid® Max Forte in the treatment of patients with respiratory allergy to Dermatophagoides/Blomia tropicalis.
NCT05049512
The LMNOP trial will be a 2-armed, open-label, randomised controlled trial (RCT), 2:1. Over a period of 18 months, children in the Multi-Nut Oral Immunotherapy Treatment (OIT) Group (experimental arm) will undergo low dose OIT to two nuts they are allergic to. At this time, children in the Standard Care Group (control arm) will be instructed to strictly avoid consuming two nuts they are allergic to. Avoiding consuming nut allergens is the standard care advice for children with peanut/tree nut allergies in Australia. The trial will assess the difference in the proportion of participants undergoing Multi-Nut OIT who can achieve sustained unresponsiveness (SU) compared to the proportion of participants avoiding nuts who develop natural tolerance (NT), i.e. grow out of their allergy. SU is when a participant can pass an oral food challenge (OFC) after having paused OIT treatment for several weeks. Participants will be between the ages of 18 and 36 months at the time of screening. The first 12 participants enrolled will be part of the pilot phase, with a total of n = 45 for the main trial. It is hypothesised that there will be a higher proportion of participants in the Multi-Nut OIT Group versus the Standard Care Group who pass the OFC following the 18-month treatment phase. That is, a higher proportion of participants in the Multi-Nut OIT Group will achieve SU compared to participants in the Standard Care Group achieving NT.
NCT03265262
Background: The need for an oral food challenge (OFC) surrogate is growing in line with the continuous increase in the prevalence and severity of paediatric food allergy. The basophil activation test (BAT) has recently been reported as a promising tool for predicting the outcome of OFC in children. Objective: We make the hypothesis that BAT might improve the sensitivity of food allergy diagnosis and spare part of current OFC in paediatric patients attending allergy departments in Marseille APHM University hospitals. Methods: BAT will be performed in parallel with OFC in 100 paediatric patients receiving OFC during a diagnostic or follow-up procedure. Expected results: Good concordance of BAT and OFC results leading to potential OFC replacement by BAT in at least 50% of the study population
NCT06993103
PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy. There will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \& 6 weeks and 6 \& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \[including anxiety and depression symptoms and health-related quality of life\] along with infant cow's milk allergy symptoms.
NCT05424731
This is an open label expanded access program for male and female patients 2 years or older, to provide continued desensitization treatment with DBV712 250 mcg.
NCT06633250
The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's milk protein allergy (CMPA).
NCT04184700
Lactobacillus GG (LGG) is able to exert long lasting effects in children with atopic disorders. Nutramigen LGG accelerates tolerance acquisition in infants with cow's milk allergy. The mechanisms of these effects are still largely undefined. The effect of LGG could be related at least in part by the immunoregulatory role played by LGG. This probiotic can balance the generation of cytokines possibly involved in IgE- or non-IgE-mediated cow's milk allergy Interleulkin (IL)-4, IL-5, IL-10, IFN-γ , TGF-β, and TNF-Υ), which can contribute to modulation of inflammatory processes. The investigators have demonstrated that children with IgE-mediated CMA produce significantly higher level of IL-4 and IL-13 in response to cow's milk protein, and that tolerance is associated with a marked reduction of IL-13 production and a concomitant increased frequency of IFN-γ releasing cells. Epigenetics studies the heritable (and potentially reversible) changes of the genome inherited from one cell generation to the next which alter gene expression but do not involve changes in primary DNA sequences, highlighting the complexity of the inter-relationship between genetics and nutrition. There are three distinct, but closely interacting, epigenetic mechanisms (histone acetylation, DNA methylation, and non-coding microRNAs) that are responsible for modifying the expression of critical genes associated with physiologic and pathologic processes. The profile of epigenetic modifications associated with Th lineage commitment, coupled with the sensitivity of the early developmental period, has led to speculation that factors that disrupt these pathways may increase the risk of allergic diseases. Specifically, effects on DNA methylation and endogenous histone deacetylase inhibitors acting on specific pathways (Th1 and T regulatory cell differentiation) may favour Th2-associated allergic differentiation. MicroRNAs are another structural components of an epigenetic mechanism of post-transcriptional regulation of messenger RNA translation. It has been recently identified a specific Th2-associated microRNA (miR-21) that is critical for the regulation of Th cell polarization. It has been previously demonstrated an inverse DNA methylation pattern of cytokines involved in Th2 response (IL-4, IL-5) compared with cytokines involved in Th1 response (IL-10, INF- y) in children with CMA acquiring oral tolerance, with the most pronounced effects in those treated with Nutramigen LGG.