Food Allergy

Dentin hypersensitivity (DH) causes sharp, short pain from exposed dentin triggered by chemicals, temperature, or touch. It commonly affects older adults and varies widely in prevalence. This research evaluates the effectiveness of Casein phosphopeptide paste (CPP-ACP) alone or combined with a diode laser called Lasotronix in treating DH, as limited studies have explored this combination. The study involves four groups: one receiving CPP-ACP paste application only, one receiving diode laser therapy only, a third receiving both CPP-ACP and laser treatments, and a control group with no treatment. Lasotronix uses a 635nm wavelength laser designed for safe and effective bio-stimulation and photo-disinfection, while CPP-ACP paste aims to reduce pain by managing dentin sensitivity. Participants aged 25 to 65 with at least one sensitive, vital tooth without decay or defective restoration will be involved. They will undergo treatment and follow-up to assess dentin hypersensitivity over three months. Researchers will monitor pain levels and treatment effects, ensuring safety and adherence to the study protocol throughout the trial period.

This research observes children who took part in the TEMPO clinical trial during their first year of life to understand if their early feeding patterns affect the development of allergies or infections in childhood. The study follows these children up to 7.5 years to gather information on allergic symptoms, infections, and related medical care. It is an observational study without additional treatments or interventions. Participants complete self-administered digital questionnaires every three months using a smartphone, tablet, or computer. These questionnaires collect data on allergies, infections, medication use, medical device use, hospitalizations, and emergency room visits. The study is entirely virtual and decentralized, allowing families to participate remotely. Throughout the study, parents provide information via regular online questionnaires, helping researchers track their child's health over time. The main measurements include parent-reported symptoms, medication or device use, and healthcare visits related to allergies and infections. The study runs until March 2029 and includes children aged 3 to 10 years who completed the original TEMPO study.

Researchers are investigating the long-term outcomes of children and young people who completed an 18-month course of oral immunotherapy (OIT) for peanut, egg, or milk allergy. The study aims to compare changes in health-related quality of life (HRQL) up to 5-15 years after stopping OIT, focusing on participants who achieved remission and those who did not. This observational study involves participants from four earlier clinical trials related to OIT treatment for these allergies. Participants will attend one follow-up visit where several tests and evaluations will take place. These include a blood test to measure specific immunoglobulin E (sIgE) levels related to peanut, egg, or milk allergies, and a skin prick test to assess allergy status using various extracts like histamine, saline, house dust mite, rye grass, and the relevant food allergen. Blood collection may be via venipuncture or fingerprick depending on feasibility. Plasma and blood cells will be stored for future research. During the single study visit, participants will complete allergy questionnaires, and blood and skin tests will be conducted to gather data on immune markers and allergy status. Researchers will measure changes in HRQL and the incidence and severity of allergic reactions over the years following OIT. The visit is expected to last about two hours, and results will help understand the long-term effects of OIT on food allergy remission and quality of life.

Food Protein Induced Enterocolitis Syndrome (FPIES) is a type of non-IgE mediated food allergy that usually occurs in infancy and is often not well known by clinicians. The study aims to collect clinical information and allergy test results from children diagnosed with the acute form of FPIES and to observe their condition over three years. It seeks to better understand the evolution of FPIES, including atypical forms, with no prior prospective data available from France. Children diagnosed with acute FPIES will be followed in this national prospective study conducted at sixteen French centers. Allergy tests such as oral food challenges, skin prick tests, and IgE blood tests will be used for diagnosis and monitoring. Patients will be seen at an initial visit and then annually for up to three years. If tolerance to the offending food is not acquired, an oral food challenge will be performed in the hospital for confirmation. Participants will undergo yearly allergist visits for evaluation of symptoms and allergy testing. Researchers will measure the rate of tolerance acquisition to foods over one, two, and three years post-inclusion, as well as the progression to IgE sensitization and clinical IgE-mediated allergy. Additional outcomes include the presence of multiple FPIES episodes and related atopic conditions. The study will provide insights into the natural history and management of FPIES in children.

Researchers are conducting a non-interventional, observational study to understand patients in Germany receiving dupilumab for eosinophilic esophagitis (EoE). The study focuses on patients' medical history, socio-demographic and disease characteristics, other related conditions, concurrent therapies, and prior EoE treatments. It also aims to evaluate the long-term effects of dupilumab on disease symptoms and patients' quality of life over a two-year period. Participants in this study are those already prescribed dupilumab by their treating physicians in routine clinical practice; no treatments are administered by the study itself. The study observes dupilumab use patterns, safety, and effectiveness during the two years of follow-up. Patients will be followed for approximately 24 months after starting dupilumab treatment with assessments at multiple timepoints to track changes in symptoms, biopsy results, and quality of life measures. During the study, participants will undergo evaluations including medical history review, clinical symptom assessment, endoscopic scoring, esophageal biopsies, and questionnaires on anxiety, depression, and quality of life. Researchers will also collect data on hospitalizations and sick leave related to EoE. Safety will be monitored throughout, and the total participation time for each person is about two years, within a four-year overall study timeline.

The FARE Patient Registry is a prospective observational study focused on collecting detailed health and basic information about individuals living with food allergies. Its purpose is to encourage open sharing of de-identified data and to support participation in clinical trials, ultimately aiming to advance scientific discoveries related to food allergy causes and contributing factors. This registry does not involve any treatment or interventions but gathers real-world experiences from participants with food allergies. It serves as a platform for the food allergy community to contribute data that can help researchers understand the extent and etiology of food allergies. Participants provide their health information and experiences, which are stored in the registry for ongoing research use. The main outcome measured is the creation of a registry that characterizes food allergies and factors influencing their development. The study is observational, with no interventions, and participation can continue until the study end date in August 2027.

Researchers are evaluating the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend called FODZYME® on gastrointestinal symptoms in adults who experience self-reported bloating. The study focuses on how this enzyme blend affects symptoms such as bloating and abdominal pain, which are often triggered by fermentable carbohydrates known as FODMAPs. This is a randomized, double-blind, placebo-controlled crossover trial that aims to provide a more flexible alternative to the restrictive Low FODMAP Diet by breaking down FODMAPs before they ferment in the colon. Participants will take the enzyme blend or a placebo with each meal, snack, or substantial beverage, applying it directly to their food. The trial is divided into two main periods: half the participants will start with the enzyme blend for four weeks followed by a two-week washout and then switch to placebo for another four weeks; the other half start with placebo and then switch to the enzyme blend after the washout. The study product is designed to target specific FODMAPs like fructan, GOS, and lactose and is intended for adults with or without IBS symptoms. During the study, participants will complete daily questionnaires and assessments over about 19 weeks, including patient-reported outcome measures for bloating, gastrointestinal symptoms, abdominal pain, food-related quality of life, and anxiety. The study is conducted remotely, allowing participants to complete assessments at home using a smartphone app. Safety is monitored by excluding those with known allergies to corn or previous reactions to digestive enzyme supplements, and researchers will review changes in bloating symptoms as the primary outcome.

Researchers are evaluating vonoprazan, a drug taken once daily at 20 mg, in adults with eosinophilic esophagitis (EoE), a condition characterized by a high number of eosinophils in the esophagus. The study aims to compare vonoprazan to a placebo to see how many participants achieve a peak eosinophil count below 15 eosinophils per high-power field after 12 weeks of treatment. This phase 2, randomized, double-blind study is sponsored by Phathom Pharmaceuticals, Inc. and involves adult participants who meet specific clinical and diagnostic criteria for EoE. Participants are randomly assigned to receive either vonoprazan 20 mg daily for 12 weeks followed by an additional 12 weeks at the same dose, or placebo for 12 weeks followed by 12 weeks of vonoprazan 20 mg daily. The study is conducted across multiple centers and includes a double-blind design to compare the safety and efficacy of vonoprazan against placebo initially and then evaluate continued treatment effects up to 24 weeks. During the trial, participants will be monitored through various assessments including esophageal biopsies to measure eosinophil counts, electronic diaries documenting dysphagia episodes, and endoscopic scoring for EoE severity. The main outcome is the number of participants achieving reduced eosinophil levels at week 12. Secondary assessments include changes in dysphagia days, endoscopic reference scores, and eosinophil counts from baseline to week 12. Safety and adherence will be tracked throughout the study period, with participant involvement expected for up to 24 weeks.

Researchers are evaluating LY3537021 to see how well it controls nausea and vomiting caused by chemotherapy in adults with cancer. This phase 2, double-blind, placebo-controlled study aims to assess both the effectiveness and safety of LY3537021 when added to standard antiemetic treatments. Participants are adults who have not previously received chemotherapy and are planned to receive specific chemotherapy drugs. Before chemotherapy, participants receive either LY3537021 or a placebo, both given as a subcutaneous injection. Alongside this, they receive standard of care antiemetic therapies, which may be given orally, intravenously, or through the skin. The chemotherapy drugs used include cisplatin or anthracycline and cyclophosphamide, administered intravenously. The study includes a randomized assignment to one of the two treatment groups and is expected to last about two months for each participant. Participants will be monitored for nausea and vomiting responses up to 120 hours after chemotherapy infusion. Researchers will collect data on complete response rates, nausea levels, and medication use. Pharmacokinetics of LY3537021 will also be assessed during the treatment cycles. Safety will be monitored throughout the study, and participants will be involved until all study parts are completed, with various assessments done at regular intervals.

Researchers are evaluating the effects of a butyrate and polyphenol formulation on gut health and related symptoms in healthy adults aged 25 to 70 who experience moderate to severe gastrointestinal discomfort. The study aims to understand how this formulation affects the gut microbiome and gastrointestinal symptoms using questionnaires and lab assessments. This is a double-blind, randomized, placebo-controlled study sponsored by Supplement Formulators, Inc. Participants will be randomly assigned to receive either the butyrate plus polyphenol formulation or a placebo. The treatment period lasts 14 days, during which participants take the assigned supplement. The study includes laboratory testing to assess the gut microbiome and various questionnaires to evaluate gastrointestinal symptoms and quality of life. During the study, participants will complete laboratory assessments and several questionnaires, including the Gastrointestinal Symptom Rating Scale for Irritable Bowel Syndrome, digestion-related quality of life surveys, and stool form scales. Researchers will monitor changes in gut microbiome composition and gastrointestinal symptoms over the 14-day period. The study also tracks safety and symptom improvement through standardized scales and quality of life measures.