Food Allergy In Children

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Review clinical trials related to Food Allergy In Children. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Pathway to Peanut Tolerance

While rigorous clinical trials have established peanut OIT as a promising therapy capable of inducing desensitization and even remission, its transition to routine clinical practice requires robust real-world evidence. Current management relies on strict avoidance, and the lack of reliable biomarkers to predict long-term success remains a significant barrier to the wider, more accessible application of OIT. Therefore, there is a critical need to evaluate peanut OIT in pragmatic, real-world settings. Such studies are essential to understand its effectiveness and safety beyond controlled trial conditions, to identify which patients benefit most, and to develop practical monitoring strategies. Generating this evidence is a crucial step toward making this treatment a viable and optimized option for the growing global population affected by peanut allergy.

Participants needed: 125
Trial details
Age: 2-17Biological sex: AllType: InterventionalSponsor: Chinese University of Hong KongUpdated: May 19, 2026Locations: 1
Eligibility criteria

Subject's parent and/ or guardian must be able to understand and provide informe... [+4]

Any disorder in which adrenaline is contraindicated (such as hypertension or car... [+8]

Status: Recruiting

Boiled Tree Nut for Oral Immunotherapy in Food-allergic Children

As the global prevalence of food allergy steadily increases, tree nut (TN) becomes one of the main triggers of food-allergic reactions and food anaphylaxis. Since there is no effective cure, TN-allergic patients and their families must continue to live with this chronic, disabling condition while avoiding allergens and responding to allergic reactions with emergency treatment. An emerging experimental treatment for food allergy is oral immunotherapy (OIT). Tree nut OIT appears promising in preliminary studies but there are concerns about the high risk of adverse reactions to TNs used in the treatment. The rate of remission with TN OIT is also lacking. Identification of OIT regimes with increased efficacy and safety is urgently needed. The investigators revealed that boiled cashews had lower allergenic potential but retained mast cell reactivity. The aim of this proposed study is to investigate the efficacy and safety of a novel treatment strategy for TN-allergic individuals, whereby the investigators hypothesized that consuming increasing quantities of boiled cashews can induce desensitization/ remission to roasted tree nuts in children with cashew allergies.

Participants needed: 75
Trial details
Phase: Phase 2Age: 2-17Biological sex: AllType: InterventionalSponsor: Chinese University of Hong KongUpdated: May 15, 2026Locations: 1
Eligibility criteria

Aged between 2 year and 17 years of age; [+4]

History of severe anaphylaxis (as defined by persistent hypotension, collapse, l... [+13]

Status: Recruiting

Tolerance Results and Immune Mechanisms in Cow´s Milk and/or Hen´s Egg Allergic Children Following Natural Evolution or Oral Immunotherapy

Allergy to Cow's milk and hen´s egg proteins are the most common causes of food allergies in early childhood and are associated with the occurrence of adverse events that may be life-threatening, quality of life impairment and negative nutritional and health economic impact. However, contrarily to other food allergy models such as nuts/peanut allergy, milk and egg allergy have greater chances of natural resolution. While around 50% of children may outgrow milk or egg allergy by the age of 5 years old, only 22% of peanut allergic children at the age of 4 years can tolerate this food. However, it is also documented that, at 14 years of age, the persistence of milk and egg allergy still affects around 30% of these children. Standard of care relies on food avoidance and treatment of accidental reactions, but this approach is unsatisfactory because adverse events and quality of life limitations still remain. Milk and egg Oral Immunotherapy (OIT) is the most promising therapeutic alternative and showed good results to induce Desensitization (ability to tolerate the food while it is regularly taken) but insufficient efficacy to achieve Sustained Unresponsiveness (SU) (ability to tolerate the food after a period of avoidance). In the day-to-day practice, families and allergists of milk and egg allergic children frequently face the following dilemma: what is the best approach? Keep waiting for natural resolution or embarking in OIT? At the moment, there are only very limited data to guide this decision, specially in children with mild to moderate allergy, that still after 6 years of age withhold relevant chances of naturally outgrowing their allergy. Our objective is conducting a longitudinal cohort-study of children undergoing food avoidance and children undergoing OIT to assess biomarkers of natural allergy resolution/persistence and OIT Desensitization/Sustained Unresponsiveness trajectories.

Participants needed: 68
Trial details
Phase: Phase 1, Phase 2Age: 4-17Biological sex: AllType: InterventionalSponsor: Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUpdated: Feb 27, 2026Locations: 1
Eligibility criteria

Cow´s Milk and/or Hen´s Egg allergic patients 4 to 10 years old [+7]

Positive reaction in the entry open oral food challenge with a baseline Elicitin... [+22]

Status: Recruiting

Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen´s Egg Allergy. CompITO Study

This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children

Participants needed: 40
Trial details
Phase: Phase 2, Phase 3Age: 6-16Biological sex: AllType: InterventionalSponsor: Pablo Rodríguez del RioUpdated: Feb 18, 2026Locations: 1
Eligibility criteria

Patients 6 to 16 years old [+3]

sIgE levels to milk >35kUA/L for milk allergic subjects and egg > 35kUA/L for mi... [+4]

Status: Not yet recruiting

Sustained Unresponsiveness (SU) to Cashew Nut Protein Following Oral Allergen-Specific Immunotherapy

This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy of Cashew Nut Protein Immunotherapy: A Protocol of a Single-Center Randomized Controlled Trial in the Pediatric Population", NCT06328504. At the end of the original RCT all participants will undergo an open Oral Food Challenge (OFC) to assess desensitization after 3 months on the maintenance dose of OIT. Patients who have completed the first part of the study will be invited to the current part of the project: * First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with cashew nut protein (1200mg) for the next 8 months (+/- 3 weeks). * Second arm (initial control group - one year on a cashew nut elimination diet) - patients will begin OIT following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months (+/- 3 weeks). After an additional 8 months (+/- 3 weeks) of OIT, all study participants will undergo a 4-week cessation of treatment, followed by an open Oral Food Challenge (OFC) to assess the development of sustained unresponsiveness (SU).

Participants needed: 39
Trial details
Age: 4-17Biological sex: AllType: InterventionalSponsor: Medical University of WarsawUpdated: Sep 8, 2025Locations: 1
Eligibility criteria

Cashew nut allergy confirmed prior to the initiation of immunotherapy [+3]

Severe asthma [+18]

Status: Not yet recruiting

Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Allergen-specific Immunotherapy

This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554. At the end of the original RCT all participants will undergo an open Oral Food Challenge (OFC) to assess desensitization after 3 months on the maintenance dose of OIT. Patients who have completed the first part of the study will be invited to the current part of the project: * First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with low dose of sesame protein (300mg) for the next 8 months (+/- 3 weeks). * Second arm (initial control group - one year on a sesame elimination diet) - patients will begin OIT following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months (+/- 3 weeks). After an additional 8 months (+/- 3 weeks) of OIT, all study participants will undergo a 4-week cessation of treatment, followed by an open Oral Food Challenge (OFC) to assess the development of sustained unresponsiveness (SU).

Participants needed: 39
Trial details
Age: 3-17Biological sex: AllType: InterventionalSponsor: Medical University of WarsawUpdated: Aug 6, 2025Locations: 1
Eligibility criteria

Sesame allergy confirmed before starting immunotherapy [+3]

Severe asthma, [+13]

Status: Recruiting

The Role of NIchel and LTPs Sensitization in Functional Gastrointestinal Disorders: the NILT Study

Non-specific lipid transfer proteins (nsLTPs) are currently recognized as the most prevalent cause of primary IgE-mediated food allergy in Mediterranean populations and constitute a leading trigger of anaphylactic reactions. In Italy, the prevalence of LTP sensitization is estimated at 2-2.4% in adults and approximately 9% in children, with marked geographic variation. Specifically, higher prevalence rates are observed in central and southern regions and on the islands (21.3%-27.2%) compared to the northern regions (approximately 11%). LTPs are ubiquitous panallergens, widely expressed throughout the plant kingdom. They represent the major allergens within the Rosaceae family in individuals not sensitized to birch pollen and have also been identified and characterized in numerous plant-derived foods, including nuts, legumes, rice, maize, beer, spelt, and wheat. The clinical spectrum of LTP hypersensitivity is highly heterogeneous. While a significant proportion of sensitized individuals remain asymptomatic, others may present with localized reactions such as contact urticaria or oral allergy syndrome (OAS). More severe cases may involve gastrointestinal symptoms (e.g., vomiting, epigastric discomfort, abdominal pain), cutaneous and respiratory manifestations, and systemic responses up to anaphylactic shock. Nickel is a ubiquitous metal employed in a wide range of industrial applications and consumer products, including stainless steel, metal plating, various alloys, and inexpensive jewelry. It is also naturally present in both animal and plant-based food sources (e.g., cereals, cocoa, legumes, fresh fruits and nuts, fish). Nickel is the most common sensitizer in allergic contact dermatitis, affecting approximately 20% of the general population and around 10% of the pediatric population. Sensitization to nickel involves a delayed-type (Type IV) hypersensitivity reaction and is not IgE-mediated. Clinical manifestations range from localized allergic contact dermatitis to systemic involvement, referred to as systemic nickel allergy syndrome (SNAS), which is characterized predominantly by gastrointestinal symptoms, although respiratory and other systemic manifestations can also occur. Gastrointestinal symptoms such as gastroesophageal reflux disease (GERD), functional dyspepsia, abdominal pain, and altered bowel habits, when not associated with overt allergic signs or underlying organic disease, are typically classified as functional gastrointestinal disorders (FGIDs). Several studies report that up to 40% of adult patients with FGIDs exhibit nickel sensitization; however, data in the pediatric population remain scarce. Chelanik® is a dietary supplement designed to support individuals with nickel hypersensitivity. It contains bioactive components purported to exert immunomodulatory and anti-inflammatory effects. Nevertheless, in vitro human data directly demonstrating its activity on lymphocyte function are currently lacking. This prospective, experimental, single-center study aims to determine the prevalence of sensitization to LTP and nickel among patients presenting with functional dyspepsia or irritable bowel syndrome (IBS), and to assess in vitro the potential immunomodulatory effects of Chelanik® on peripheral blood lymphocytes from individuals with nickel allergy.

Participants needed: 100
Trial details
Age: 4-65Biological sex: AllType: ObservationalSponsor: Federico II UniversityUpdated: Aug 6, 2025Locations: 1
Eligibility criteria

Age at least of 4 years [+3]

Age < 4 years [+1]

Status: Recruiting

Evaluation of The Food Allergy Mastery Program

The proposed research project will evaluate a novel behavioral intervention that promotes early adolescent food allergy self-management and adjustment through 1) food allergy education, 2) problem-solving, communication, assertiveness, and anxiety management skill building, and 3) peer support.

Participants needed: 240
Trial details
Age: 10-14Biological sex: AllType: InterventionalSponsor: Children's National Research InstituteUpdated: Jul 11, 2025Locations: 1
Eligibility criteria

age 10-14 years [+4]

diagnosis of a non-IgE-mediated food allergy or food intolerance, a non-atopic c... [+1]

Status: Not yet recruiting

Improving Diagnosis of Legume Allergy in Children

In France, almost 15% of serious food allergies in children are caused by legumes, especially peanuts. Other legumes like soy, lentils, peas, lupin, chickpeas, beans, and fenugreek can also cause allergic reactions. But here's the problem: only peanuts, soy, and lupin are required to be clearly labeled on food packaging in the European Union. This makes it hard for families to know when other legumes-like peas or fenugreek-are hidden in processed foods. Avoiding all these legumes is hard-especially since many of them are used in processed foods and not always listed on the label. Right now, detailed allergy tests to evaluate the probability of allergy diagnosis are only available for peanuts and soy, and not for other legumes. LACID study has been created to find and study the proteins in lupin, fenugreek, and peas that may cause allergies and developp better allergy tests for these legumes-possibly as part of a diagnostic tool that can give clear results using just a blood sample. The goal is to help doctors and families better understand which legumes a child really needs to avoid-and which ones are actually safe to eat.

Participants needed: 90
Trial details
Age: Up to 18Biological sex: AllType: ObservationalSponsor: Central Hospital, Nancy, FranceUpdated: Jun 5, 2025
Eligibility criteria

Sensitised to lupine, fenugreek or pea

on going anti-IgE treatment or in the last 6 months

Status: Recruiting

Effect of Omalizumab in the Skin of Food Allergy Patients

The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab. If there is a comparison group: Researchers will compare non-food allergic participants (who do not receive omalizumab) to see if they experience skin barrier abnormalities. All food allergic participants will receive 4 months of Omalizumab treatment as well as two Oral Food Challenges. Participants will all undergo skin barrier assessments.

Participants needed: 40
Trial details
Phase: Phase 4Age: 1-55Biological sex: AllType: InterventionalSponsor: National Jewish HealthUpdated: May 2, 2025Locations: 1
Eligibility criteria

Participant and/or parent/legal guardian must be able to understand and provide... [+6]

Inability or unwillingness of a participant and/or parent/legal guardian to give... [+19]