Clinical trials: Milk Hypersensitivity
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
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
Cow Milk Allergy
Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula
This is a single arm, open label, multicenter intervention trial to evaluate growth parameters, cow's milk related symptoms, gastrointestinal tolerance and safety in infants with cow's milk allergy receiving a hydrolyzed protein…
- Trial name
- STORY (NCT05618704)
- Testing
- Hydrolyzed protein infant formula
- Where
- Poland
- Volunteers
- 69 people
- Sponsor
- Nutricia Research
Cow's Milk Allergy, Intolerance to Extensively Hydrolyzed Formulas
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas
This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.
- Conditions
- Cow's Milk Allergy, Intolerance to Extensively Hydrolyzed Formulas, Intolerance to Breast Milk
- Trial name
- NCT01470768
- Testing
- Amino Acid-based Formula with high DHA and ARA, Amino Acid-based Formula with lower DHA and ARA
- Where
- United Kingdom
- Sponsor
- Mead Johnson Nutrition
Food Hypersensitivity
Extensively Hydrolyzed Formula: Hypoallergenicity
The primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic.
- Trial name
- NCT01278446
- Testing
- Extensively hydrolyzed, whey protein infant formula, Extensively hydrolyzed, casein protein infant formula
- Where
- 14 sites in United States
- Sponsor
- Société des Produits Nestlé (SPN)
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
Food Allergy
ADP101 for Oral Immunotherapy in Food-Allergic Children and Adults
The purpose of this study is to assess the efficacy and safety of ADP101 in food allergic children and adults.
- Trial name
- NCT04856865
- Testing
- Low dose ADP101, High dose ADP101
- Where
- 15 sites in United States
- Volunteers
- 73 people
- Sponsor
- Alladapt Immunotherapeutics, Inc.
Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn
Infant Formula Feeding and Necrotizing Enterocolitis in Newborns
Necrotizing enterocolitis (NEC) is the most common life-threatening gastrointestinal emergency of prematurity, associated with a significant morbidity and mortality.
- Conditions
- Necrotizing Enterocolitis, Necrotizing Enterocolitis of Newborn, Sepsis Newborn, Cows Milk Allergy
- Trial name
- NCT05121753
- Testing
- Survey investigating Infant formula feeding in newborns
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Neuroganics LLC
IgE-Mediated Cow Milk Allergy
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
The goal of this clinical trial is to see if a new formula based on hydrolysed rice proteins (Rice formula) is well tolerated by infants and young children with cow's milk allergy.
- Trial name
- NCT07197814
- Testing
- Rice formula (New formula based on hydrolysed rice proteins)
- Where
- Italy
- Volunteers
- 29 people
- Sponsor
- Health and Happiness Research Limited
Food Allergy
Observatory on Cow's Milk Protein Allergy
The purpose of this study is to describe the symptoms and their evolution up to the age of 5 years in a population of newly diagnosed infants with a suspected or confirmed allergy to cow proteins, for whom the doctor prescribed…
- Trial name
- OLAF (NCT06085118)
- Testing
- Pepticate® Syneo®
- Where
- 2 sites in France
- Volunteers
- 3,000 people
- Sponsor
- Nutricia Nutrition Clinique
Stool Assessment, Skin Rash
GI Symptoms in Infants Fed Goat Milk-based Infant Formula
A cross-sectional observational survey was conducted in Brazil, Mexico, Russia, and The Netherlands by recruiting parents/legal guardians through social media.
- Conditions
- Stool Assessment, Skin Rash, Urticaria, Regurgitation
- Trial name
- NCT06755424
- Where
- Netherlands
- Volunteers
- 425 people, healthy volunteers welcome
- Sponsor
- Ausnutria Hyproca B.V.
Cow Milk Allergy
Symptoms Based Awareness Confirmation Study - CoMiSS Validation
The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to recognize cow's milk related symptoms in infants and young children.
- Trial name
- MOSAIC (NCT03004729)
- Testing
- CoMiSS questionnaire
- Where
- 10 sites in China
- Volunteers
- 300 people
- Sponsor
- Société des Produits Nestlé (SPN)
Ig-E Mediated Food Allergy
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy: This is a Phase 2b randomized, double-blind, placebo-controlled clinical trial evaluating RPT904, a next-generation anti-IgE monoclonal…
- Trial name
- NCT07220811
- Testing
- RPT904
- Where
- 37 sites in United States, Australia and 1 more
- Volunteers
- 100 people
- Sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companies
Cow's Milk Allergy
Study to Assess Hypoallergenicity of a New Amino-acid Based Infant Formula in Children With Cow's Milk Allergy
This is a prospective, controlled, multi-country study to verifying the hypoallergenicity of the new amino acid-based formula in infants and children aged< 12 years with documented cow's milk protein allergy (CMPA).
- Trial name
- RAF (NCT02414243)
- Testing
- New Amino Acid formula, Commercially available Amino Acid Formula
- Where
- Italy
- Volunteers
- 41 people
- Sponsor
- Laboratorios Ordesa
Cow's Milk Protein Allergy
Tolerance and Growth Outcomes in Children Diagnosed With Cow's Milk Protein Allergy and Prescribed an Extensively Hydrolyzed Casein Formula (Damira 2000©) in Spain
Damira 2000© is a 100% extensive casein hydrolysate (eHCF). It is formulated to help reverse growth retardation as a result of cow's milk proteins allergy (CMPA), to be well tolerated and to help improve symptoms.Damira 2000 is…
- Trial name
- DELISA (NCT06273371)
- Testing
- Damira 2000 Infant formula
- Where
- 8 sites in Spain
- Volunteers
- 61 people
- Sponsor
- Lactalis
Cow Milk Allergy
A Double-blind Randomized Controlled Trial of a Thickened Amino-acid-based Formula in Children Allergic to Cow's Milk and to Protein Hydrolysates
The purpose of this study is to evaluate the impact of a new Amino-acid based formula on allergic symptoms and growth of infants with cow's milk protein allergy and intolerant to extensively hydrolysed formulas;
- Trial name
- NCT01940068
- Testing
- Amino acid based formula
- Where
- France
- Volunteers
- 86 people
- Sponsor
- United Pharmaceuticals
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
Milk Hypersensitivity
Prevention of Cow's Milk Allergy in Children
Impact of fermented milk in prevention of cow's milk allergy in new born and infants
- Trial name
- NCT00792090
- Testing
- Fermented milk, Standard milk
- Where
- 2 sites in France
- Volunteers
- 142 people
- Sponsor
- Bledina
Allergy
Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed formula with an added probiotic in children with documented milk allergy.
- Trial name
- NCT01181297
- Testing
- Extensively Hydrolyzed Formula with a Probiotic, Extensively Hydrolyzed Formula without a Probiotic
- Where
- 2 sites in Italy, Netherlands
- Sponsor
- Mead Johnson Nutrition
Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders
A Study to Monitor the Use of an Amino Acid-Based Infant Formula
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.
- Conditions
- Cow's Milk Protein Allergy, Eosinophilic Gastrointestinal Disorders, Malabsorption/Maldigestion, Short Bowel Syndrome
- Trial name
- EAGLE (NCT02953223)
- Testing
- Free amino acid infant formula
- Where
- 29 sites in United States
- Volunteers
- 144 people
- Sponsor
- Société des Produits Nestlé (SPN)