Clinical trials: Food Safety
Peanut Allergy
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a post up-dosing…
- Trial name
- NCT03682770
- Testing
- Dupilumab, AR101
- Where
- 25 sites in United States
- Volunteers
- 148 people
- Sponsor
- Regeneron Pharmaceuticals
Peanut Allergy
Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active…
- Trial name
- PEOPLE (NCT03013517)
- Testing
- Viaskin Peanut 250µg
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 300 people
- Sponsor
- DBV Technologies
Peanut Allergy
Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children
The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: To assess the efficacy of Viaskin Peanut after up to 36…
- Trial name
- OLFUS-VIPES (NCT01955109)
- Testing
- Viaskin Peanut 250 mcg
- Where
- 22 sites in United States, Canada and 2 more
- Volunteers
- 171 people
- Sponsor
- DBV Technologies
Safety and Tolerability in Healthy Volunteers
Safety and Tolerability Evaluation of BP-LT
This study evaluates the safety and tolerability of the food ingredient BP-LT when added to a daily diet. BP-LT is a stable protein ingredient being functional in the gastrointestinal tract and without systemic absorption.
- Trial name
- NCT07819695
- Testing
- BP-LT
- Where
- Bangladesh
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bactolife A/S
Cow's Milk Allergy
Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children
Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's milk allergy (CMA) in children with symptoms…
- Trial name
- APTITUDE (NCT04492683)
- Testing
- DBV1605
- Where
- 33 sites in United States, Canada and 2 more
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- DBV Technologies
To Assess the Safety and Tolerabiltiy of an Amino Acid Composition in Subjects With Sickle Cell Disease, Anemia, Sickle Cell
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
This is an open-label study to understand the safety and tolerability of AXA4010, a novel composition of amino acids in adult and adolescent subjects with sickle cell disease over 12 weeks.
- Conditions
- To Assess the Safety and Tolerabiltiy of an Amino Acid Composition in Subjects With Sickle Cell Disease, Anemia, Sickle Cell, Sickle Cell Anemia, Sickle Cell Disorders
- Trial name
- NCT04134299
- Testing
- AXA4010
- Where
- 4 sites in United States
- Volunteers
- 9 people
- Sponsor
- Axcella Health, Inc
Enteral Feeding
Nutritional Tolerance and Safety of a Tube Feeding Formula in Children
To assess the efficacy, tolerance, and safety of a pediatric enteral formula in children.
- Trial name
- NCT05838495
- Testing
- formulated liquid diet
- Where
- Canada
- Volunteers
- 27 people
- Sponsor
- Société des Produits Nestlé (SPN)
Growth, Allergy
Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein
The purpose of this study is to assess growth and global tolerance in healthy new born infants with minor gastrointestinal troubles and/or allergic risk, fed an experimental partially hydrolyzed rice protein infant formula.
- Trial name
- Rose (NCT00997971)
- Testing
- Modilac Rose 1
- Where
- 9 sites in France
- Volunteers
- 86 people
- Sponsor
- Sodilac
Milk Allergy
Formula for Children With Cow's Milk Allergy
The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy.
- Trial name
- NCT02317952
- Testing
- Experimental Extensively Hydrolyzed Formula, Active Comparator Formula
- Where
- 18 sites in United States
- Volunteers
- 90 people
- Sponsor
- Perrigo Nutritionals
Allergy, Peanut
Efficacy and Safety of QGE031 (Ligelizumab) in Patients With Peanut Allergy
This was a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) SC q4w (subcutaneous injection…
- Trial name
- NCT04984876
- Testing
- ligelizumab
- Where
- 55 sites in United States, Australia and 8 more
- Volunteers
- 211 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Hepatitis B
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Oral HRS5091 in Healthy Subjects and Chronic Hepatitis B Patients
The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS5091.
- Trial name
- NCT04480294
- Testing
- HRS5091
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Milk Hypersensitivity
Tolerability and Safety of An Infant Formula
The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.
- Trial name
- NCT00938483
- Testing
- Nutramigen Lipil (Infant formula)
- Volunteers
- 108 people
- Sponsor
- Perrigo Nutritionals
Peanut Allergy
Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy
The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device) in peanut allergic subjects.
- Trial name
- NCT01170286
- Testing
- Whole peanut extract
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- DBV Technologies
Allergic Reactions
Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
The study is to assess the safety of neffy or IM Adrenalin in patients who are experiencing allergic reactions after an OFC, allergen Immunotherapy (AIT), or other allergy challenge that may require epinephrine intervention.
- Trial name
- NCT06834165
- Testing
- Neffy, Adrenaline
- Where
- 6 sites in United States
- Volunteers
- 600 people
- Sponsor
- ARS Pharmaceuticals, Inc.
Peanut Allergy
Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy
This clinical research study investigates the safety, tolerability and efficacy of a peanut SLIT-tablet in adults, adolescents, and children with peanut allergy.
- Trial name
- NCT05440643
- Testing
- Peanut SLIT-tablet
- Where
- 42 sites in United States, Canada
- Volunteers
- 209 people
- Sponsor
- ALK-Abelló A/S
Peanut Allergy
Oral Immunotherapy for Peanut Allergic Patients
Multicenter, double-blind, randomized, placebo-controlled phase I/II study to determine the safety, tolerability, potential efficacy and dose finding of INP20, an oral immunotherapy in peanut-allergic patients.
- Trial name
- NCT04163562
- Testing
- INP20
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- InnoUp Farma S.L.
Allergy
A Safety and Efficacy Study of Xolair in Peanut Allergy
This is a 38-week, randomized, double-blind, placebo-controlled, parallel group trial of approximately 150 patients who have a history of immediate hypersensitivity reaction to peanut protein.
- Trial name
- NCT00086606
- Testing
- Xolair (omalizumab)
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Genentech, Inc.
Cow's Milk Protein Allergy
Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides
The primary objective of the study is to show that infants with cow milk protein allergy (CMPA) fed with a new FSMP infant formula with reduced level of protein \& with 2 Human Milk Oligosaccharides (HMOs) (test formula) have a…
- Trial name
- CINNAMON (NCT03085134)
- Testing
- Test infant formula with HMOs, Control infant formula without HMOs
- Where
- 42 sites in Belgium, Hungary and 5 more
- Volunteers
- 194 people
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy
A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878
Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple ascending dose trial in healthy younger and elderly adult subjects, with an open-label, randomised, crossover arms to assess the effect of…
- Trial name
- NCT03244228
- Testing
- HTL0016878
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Nxera Pharma UK Limited
Allergy;Food
A Hypoallergenicity Study on a New Rice-Based Hydrolysate Formula
Cow's Milk Allergy (CMA) affects between 2-3% of young children but its severity varies between regions/countries. While the long-term prognosis for CMA is good, with the majority (80-90%) of children outgrowing their allergy by…
- Trial name
- CHARM (NCT04519827)
- Testing
- New Rice-based hydrolysate, Amino Acid-based infant formula
- Where
- 4 sites in Italy, Spain
- Volunteers
- 39 people
- Sponsor
- Dr. Schär AG / SPA