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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.
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.
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.
NCT06771440
Antibiotic allergy labels (AAL) are reported in 7% of inpatient's charts, especially for beta-lactams (86% of AAL, i.e., prevalence of 6%). They are associated with increased length of hospital stay, and use of second-line and broad-spectrum antibiotics. Allergy workups are able to invalidate the majority of these AAL but are time-consuming and require invasive skin and provocation testing. The investigators recently evaluated, for the first time in Europa, a strictly non-invasive delabeling protocol using a questionnaire, medical file search and contact with primary care health care workers in 200 adult internal medicine inpatients with a beta-lactam AAL. Up to half of the AAL could be removed or refined, demonstrating the potential of this strategy. In this project, they aim to assess the impact of using the non-invasive 'AAL-fact-check' tool in a multicenter study, on antibiotic selection, and clinical, antimicrobial, and economic endpoints, as compared with the standard of care (i.e., no AAL-fact-check tool).
NCT07279467
This is a multi-center, mechanistic study. It is designed to learn more about signs in the body, called biomarkers, that might show if someone will have a reaction to peanut during a feeding test. The trial will enroll children ages 12 months to17 years old who are suspected of having an allergy to peanut. The primary objective is to identify a biomarker (or a combination of biomarkers) that will predict oral food challenge (OFC) (feeding test) results for participants with suspected peanut allergy.
NCT07069439
This study aims to evaluate the psychometric properties of the Turkish version of the Parent-reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q), a disease-specific instrument assessing the health-related quality of life (HRQoL) in caregivers of children with suspected or confirmed drug hypersensitivity reactions. The P-DrHy-Q is designed to capture the psychosocial burden experienced by caregivers and includes two main domains: Mental Health and Social Activity. This study involves a forward-backward translation process, cultural adaptation, internal consistency analysis, and test-retest reliability assessment in a Turkish caregiver population.
NCT04259359
Venom immunotherapy (VIT) is an established treatment for Hymenoptera venom allergy and provides long-term protection from further generalized reactions in almost all patients. However, it is still unclear why bee VIT is less effective than vespid VIT. The preliminary data show that not only predominant Api m 10 sensitization but also other predominant sensitizations may be relevant as risk factors for treatment failure. Interestingly, all patients with a predominant Api m 10 sensitization who received bee VIT with a venom preparation with a supposed lack of Api m 10 tolerated sting challenges. Therefore, a multicenter study with a sufficient number of patients with treatment failure is urgently required, to clarify if predominant sensitization to a bee venom allergen is a risk factor for treatment failure. If predominant sensitization is a risk factor and caused by underrepresented components in bee venom preparations used for VIT, bee venom preparations may be optimized in the future and patients would benefit from a more effective VIT.
NCT06732414
Background: Allergic or sinus diseases can affect the skin, sinuses, airways, and other parts of the body. Examples include pollen and environmental allergies, food allergies, asthma, and eczema. To learn more about how to prevent and treat these diseases, researchers need to study data, blood, fluid, and tissue samples from people affected by them. Objective: To collect data, blood, fluid, and tissue samples from people with allergic or sinus diseases. Eligibility: People aged 3 to 100 years with allergic or sinus diseases. Design: Participants will have at least one clinic visit, and most participants will have a baseline visit, annual visit, and an end of study visit. The duration of the study is 1 to 3 years. During the first clinic visit, the following procedures will be done to collect data, blood, fluid, and tissue samples: * Blood will be collected. * Cells and fluid may be collected from the inside of the nose using a long swab, and a small piece of skin may be scraped from inside the nose. * Skin cells will be collected by rubbing with a cotton swab. * A urine sample will be collected. * Allergy skin prick tests. Allergy-causing substances will be placed on the back or arm and the skin underneath gently scratched. If the participant is allergic to the substance, the skin may become red, itchy, and swollen locally ( at the site of the test). * Lung function test. Participants will breathe into a machine that measures the air moving in and out of their lungs. * If, as part of their routine care, participants are undergoing procedures such as having nasal polyps removed, skin tissue samples taken, or gastrointestinal biopsies, additional tissues may be collected for this study. * Participants will complete online questionnaires regarding their symptoms, health, and life. Participants may return for more visits for up to 3 years.
NCT03539692
This is a protocol for prescreening of participants who would like to be in clinical studies in our Center at Stanford.