Clinical trials: Food Safety
Food Allergy
Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy
This is an experimental, interventional study, following on from a clinical trial comparing the efficacy and safety of oral immunotherapy with low and high doses of sesame protein, in which patient desensitisation was achieved…
- Trial name
- NCT05923216
- Testing
- High dose OIT, Low dose OIT
- Where
- Poland
- Volunteers
- 40 people
- Sponsor
- Medical University of Warsaw
Cow's Milk Protein Allergy (CMPA)
Safety and Efficacy Evaluation of an Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy (CMPA)
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…
- Trial name
- NCT07484035
- Testing
- Feihe Extensively Hydrolyzed Formula, Nestlé Extensively Hydrolyzed Formula
- Where
- 6 sites in China
- Volunteers
- 124 people
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Peanut Allergy
Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy
The objectives of this dose-finding study for the treatment of peanut allergy are: To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize…
- Trial name
- VIPES (NCT01675882)
- Testing
- Viaskin Peanut 50 mcg, Viaskin Peanut 100 mcg, Viaskin Peanut 250 mcg
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 221 people
- Sponsor
- DBV Technologies
Peanut Allergy, Peanut Hypersensitivity
A Safety and Efficacy Study of PVX108 in Children and Adolescents With Peanut Allergy
The overall aims of this study are to demonstrate that treatment with PVX108 immunotherapy has an acceptable safety profile and is effective for reducing clinical reactivity to peanut protein in children and adolescents with…
- Conditions
- Peanut Allergy, Peanut Hypersensitivity, Peanut-Induced Anaphylaxis, Immune System Diseases
- Trial name
- NCT05621317
- Testing
- PVX-108
- Where
- 14 sites in United States, Australia
- Volunteers
- 95 people
- Sponsor
- Aravax Pty Ltd
Peanut Allergy
The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery
Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed after the initial 3 month avoidance period Secondary Objectives: Identify the basic immune mechanisms which can explain the differences in…
- Trial name
- POISED (NCT02103270)
- Testing
- Peanut Protein 4,000mg, Oat Flour, Peanut Protein 300 mg
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Stanford University
Egg Hypersensitivity
Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study
Egg allergy is common in early childhood, affecting at least one in 50 preschool children. Influenza ("'flu") vaccines contain egg protein, as the vaccine is cultured in hen's eggs.
- Trial name
- SNIFFLE-2 (NCT02111512)
- Testing
- Administration of Live attenuated influenza vaccine (LAIV)
- Where
- 29 sites in United Kingdom
- Volunteers
- 779 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Eosinophilic Esophagitis, Milk Allergy
Milk Patch for Eosinophilic Esophagitis
This is a single-site, double-blind, placebo-controlled, randomized trial to study efficacy and safety of the Viaskin® Milk Patch for children with milk induced Eosinophilic Esophagitis (EoE).
- Trial name
- SMILEE (NCT02579876)
- Testing
- Viaskin Milk 500 mcg
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Children's Hospital of Philadelphia
Peanut Allergy
Oral Low Doses Tolerance INduction Study for Peanuts
Several protocols have been proposed in scientifis literature, for oral tolerance induction (OIT) protocols for peanuts. A meta-analysis showed that the data in the literature are rather in favor of the exclusion of peanuts, and…
- Trial name
- OLDTINYpeanut (NCT04881773)
- Where
- France
- Volunteers
- 2,000 people
- Sponsor
- University Hospital, Montpellier
Cow's Milk Protein Sensitivity
Specific Oral Tolerance Induction in Children Allergic to Cow's Milk Proteins
Induction of oral tolerance in children allergic to cow's milk proteins is not risk-free. The analysis of factors that may influence the outcome is of utmost importance.
- Trial name
- NCT01641731
- Testing
- Cow's milk
- Where
- Spain
- Volunteers
- 55 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
Food Allergy, Cow's Milk Protein Allergy
GOAt Milk Formula-based Ladder Versus Cow's Milk Ladder
Children with immunoglobulin E (IgE)-mediated cow's milk allergy (CMA) who react to small amounts of baked cow's milk may require prolonged elimination.
- Conditions
- Food Allergy, Cow's Milk Protein Allergy, Cow's Milk Allergy
- Trial name
- GOAL (NCT07795957)
- Testing
- oral food challenge (OFC)
- Where
- 2 sites in Poland
- Volunteers
- 92 people
- Sponsor
- Medical University of Warsaw
Peanut Allergy
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age
The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).
- Trial name
- EPITOPE (NCT03211247)
- Testing
- Part A Viaskin Peanut 250 mcg, Part A Viaskin Peanut 100 mcg, Part B Viaskin Peanut 250 mcg
- Where
- 51 sites in United States, Australia and 6 more
- Volunteers
- 414 people
- Sponsor
- DBV Technologies
Food Allergy
Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy.
- Trial name
- NCT06261554
- Testing
- Dietary Supplement: Low dose OIT
- Where
- Poland
- Volunteers
- 39 people
- Sponsor
- Medical University of Warsaw
Peanut Allergy
High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety
In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with peanut protein in high and low dose (300mg versus 150mg) in children with peanuts allergy.
- Trial name
- NCT04415593
- Testing
- High dose of peanuts, Low dose of peanuts
- Where
- Poland
- Volunteers
- 44 people
- Sponsor
- Medical University of Warsaw
Food Allergy
A Study to Assess Primarily the Tolerability and Safety of SAR439794 After Repeated Sublingual Daily Administration in Peanut Allergic Adult and Adolescent Patients
Primary Objective: To assess tolerability and safety of SAR439794 [peanut extract (PE) sublingual immunotherapy (SLIT) adjuvanted with Glucopyranosyl Lipid A (GLA)] after repeated sublingual (SL) daily administration in peanut…
- Trial name
- NCT03463135
- Testing
- Glucopyranosyl Lipid A (GLA), Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)
- Where
- 16 sites in United States
- Volunteers
- 27 people
- Sponsor
- Sanofi
Peanut Allergies
Efficacy, Safety and Pharmacokinetics of LP-003 in Peanut Allergic Patients
This study will evaluate the safety and efficacy of LP-003 for an increasing the amount of peanut protein that people with a peanut allergy can tolerate without having allergic symptoms.
- Trial name
- NCT07785063
- Testing
- LP-003 Injection
- Volunteers
- 80 people
- Sponsor
- Longbio Pharma (Suzhou) Co., Ltd.
Cow's Milk Allergy
Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.
The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients.
- Trial name
- MERLIN (NCT06481280)
- Testing
- Test Formula
- Where
- 2 sites in Belgium, Italy
- Volunteers
- 70 people
- Sponsor
- United Pharmaceuticals
Cow's Milk Protein Allergy (CMPA)
TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)
This study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed formula in young children aged 1~3 years with diagnosed with or highly suspected CMPA in a real-world clinical practice…
- Trial name
- NCT07855796
- Testing
- Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Teyi Yinuo Health Technology Co., Ltd.
Peanut Allergy
Safety Study of Viaskin Peanut to Treat Peanut Allergy
This study evaluates the safety of Viaskin Peanut 250 µg in the treatment of peanut allergy in children from 4 to 11 years of age.
- Trial name
- REALISE (NCT02916446)
- Testing
- Viaskin Peanut 250 µg
- Where
- 32 sites in United States, Canada
- Volunteers
- 393 people
- Sponsor
- DBV Technologies
IgE-Mediated Food Allergy, Peanut Allergy
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
The purpose of this Phase III study is to evaluate the clinical efficacy and safety of remibrutinib in participants with peanut, or cow's milk ("milk", cooked and uncooked) or hen's egg ("egg", cooked and uncooked) immunoglobulin…
- Conditions
- IgE-Mediated Food Allergy, Peanut Allergy, Cow Milk Allergy, Egg Allergy
- Trial name
- NCT07768371
- Testing
- Remibrutinib
- Where
- 18 sites in United States
- Volunteers
- 576 people
- Sponsor
- Novartis Pharmaceuticals
Cashew Nut Allergy, Tree Nut Allergies
UNC Cashew Sublingual Immunotherapy
The CASCADES study will investigate the safety and efficacy of sublingual immunotherapy (SLIT) for the treatment of cashew allergy in children ages 1-11 years old. Primary efficacy will be assessed after 18 months of cashew SLIT.
- Trial name
- CASCADES (NCT07170540)
- Testing
- Cashew sublingual immunotherapy
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- University of North Carolina, Chapel Hill