Clinical trials: Milk Hypersensitivity
- Condition Milk Hypersensitivity
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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
Growth
Evaluation of Safety, Growth, Tolerance and Effects on the Intestinal Fora of a New Milk for Healthy Infants
The purpose of the study is to assess growth and tolerance in new born and infant fed an experimental infant formula with reduced total protein concentration, enriched in alpha-lactalbumin and containing a symbiotic.
- Trial name
- Pétunia (NCT00920166)
- Testing
- Pétunia 1, Regular formula
- Where
- 4 sites in France
- Volunteers
- 97 people
- Sponsor
- Sodilac
Cow Milk Protein Allergy, FPIES
Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy
This study is designed as multicentric, interventional, with two successive randomised, double-blind, crossovers. The aim of the study is to demonstrate the tolerance of an extensively hydrolysed anti-regurgitation casein-based…
- Trial name
- PANDA (NCT07592182)
- Testing
- Oral Food Challenge V2, Product administration between V4 and V5, Oral Food Challenge V3
- Volunteers
- 55 people
- Sponsor
- Lactalis
Cow's Milk Protein Allergy
The Journey of Children With Cow's Milk Protein Allergy in Mexico.
To gain insights on the application, use and effectiveness of Frisolac Gold Intensive HA and Frisolac Gold PEP AC with reference to improvement of CMPA symptoms and to determine the methodology used by Mexican Health Care…
- Trial name
- Friso02 (NCT04596059)
- Testing
- Frisolac Gold Intensive HA
- Where
- 4 sites in Mexico
- Volunteers
- 79 people
- Sponsor
- FrieslandCampina
Cow's Milk Protein Allergy
Hydrolysed Rice Formula Study
This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day…
- Trial name
- NCT06288503
- Testing
- Hydrolysed Rice Protein Formula, Cow's Milk Based Extensively Hydrolysed Formula
- Where
- 2 sites in United Kingdom
- Volunteers
- 86 people
- Sponsor
- Nutricia UK Ltd
Milk Hypersensitivity
Amino Acid Feed Children's Study
This study of the tolerance and acceptability of an amino acid based feed will assess gastrointestinal (GI) tolerance, product intake and acceptability in relation to taste, smell, texture in 20 patients between 1-10 years…
- Trial name
- NCT02569840
- Testing
- Amino Acid Feed
- Volunteers
- 30 people
- Sponsor
- Nutricia UK Ltd
Allergy
Acceptability and Palatability Study of Paediatric Amino Acid Feed
Product acceptability and palatability data from a minimum of 15 participants are required to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) for Ireland for…
- Trial name
- NCT06547346
- Testing
- Alfamino Junior
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Société des Produits Nestlé (SPN)
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
Cow's Milk Allergy
Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order.
- Trial name
- NCT02450643
- Testing
- Test extensively hydrolyzed formula, Control extensively hydrolyzed formula
- Where
- 8 sites in United States
- Volunteers
- 83 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
Dermatitis, Atopic, Eczema, Infantile
Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.
- Conditions
- Dermatitis, Atopic, Eczema, Infantile, Infant Development, Child Development
- Trial name
- GIraFFE (NCT04599946)
- Testing
- Infant formula and follow-on formula made from whole goat milk, Infant formula and follow-on formula made from cow's milk ingredients
- Where
- 12 sites in Germany, Poland and 1 more
- Volunteers
- 2,132 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited
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
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
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
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)
Cow Milk Protein Allergy
CMPA-GO Study: Growth and Safety Outcomes in Infants With CMPA Fed a Novel Extensively Hydrolyzed Formula
CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula
- Trial name
- CMPA-GO (NCT06830681)
- Testing
- New generation eHF, Commercial eHF
- Where
- Spain
- Volunteers
- 4 people
- Sponsor
- Société des Produits Nestlé (SPN)
Cow Milk Allergy
Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula
The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge…
- Trial name
- ALYCE (NCT02711163)
- Testing
- Extensively Hydrolyzed formula, Amino acid formula
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- United Pharmaceuticals
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)
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
Cow Milk Protein Allergy
Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy.
The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula.
- Trial name
- RIGHT-GO (NCT06633250)
- Testing
- Test Formula, Control Formula
- Where
- 19 sites in Germany, Italy and 1 more
- Volunteers
- 104 people
- Sponsor
- Société des Produits Nestlé (SPN)