Clinical trials: Cows Milk Allergy
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 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)
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
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 Allergy
Growth, Safety and Tolerance of a Rice Protein Hydrolysate Formula in Infants With Cow's Milk Protein Allergy
This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an…
- Trial name
- GRITO-14 (NCT02405923)
- Testing
- HRF, eHF
- Where
- 5 sites in France, Spain
- Volunteers
- 117 people
- Sponsor
- Laboratorios Ordesa
Cow Milk Allergy
Synbiotic Extensively Hydrolysed Feed Study
This study of the tolerance and acceptability of a extensively hydrolysed formula (eHF) containing pre- and probiotics will assess gastrointestinal (GI) tolerance, product intake and acceptability in 40 infants (aged <13 months)…
- Trial name
- NCT03874104
- Testing
- Extensively Hydrolysed Formula containing Pre- & Probiotics
- Where
- 8 sites in United Kingdom
- Volunteers
- 35 people
- Sponsor
- Nutricia UK Ltd
Cows Milk Allergy
Synbiotics Cohort Study
Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics.
- Trial name
- NCT05046418
- Testing
- Hypoallergenic formula containing synbiotics
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Nutricia UK Ltd
Cow Milk Allergy
Hypoallergenicity Evaluation 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
- NCT03236207
- Testing
- Test extensively hydrolyzed formula, Control extensively hydrolyzed formula
- Where
- 12 sites in United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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'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)
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 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)
Cow's Milk Protein Allergy
Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula in Infants and Young Children With Cow's Milk Protein Allergy
The purpose of the study is to determine whether a new hydrolyzed rice protein-based formula is hypoallergenic in infants and young children with documented Immunoglobulin E (IgE)-mediated Cow Milk Protein Allergy (CMPA).
- Trial name
- RIGHT-HY (NCT06633289)
- Testing
- Experimental formula, Control formula
- Where
- 11 sites in Germany, Italy and 1 more
- Volunteers
- 43 people
- Sponsor
- Société des Produits Nestlé (SPN)
Cow's Milk Allergy
Extensively Hydrolyzed Infant Formula in Infants and Children With Cow's Milk Allergy
This is a multi-center, randomized, double-blind, placebo-controlled food challenge to be conducted in infants or children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the experimental…
- Trial name
- NCT04910373
- Testing
- Experimental Extensively Hydrolyzed Formula
- Where
- 4 sites in United States
- Volunteers
- 1 people
- Sponsor
- Abbott Nutrition
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
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
Food Allergy
Efficacy and Safety of Viaskin Milk in Children With IgE-Mediated Cow's Milk Allergy
The objectives of this study are to evaluate the safety and efficacy of Viaskin Milk after 12 months of epicutaneous immunotherapy (EPIT) treatment, for desensitizing IgE-mediated cow's milk allergic children and to assess the…
- Trial name
- MILES (NCT02223182)
- Testing
- Viaskin Milk 150 mcg, Viaskin Milk 300 mcg, Viaskin Milk 500 mcg
- Where
- 17 sites in United States, Canada
- Volunteers
- 198 people
- Sponsor
- DBV Technologies
Infant Development
Acceptability and Tolerance Study of an Amino Acid Formula with HMOs
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of a hypoallergenic amino acid infant formula with HMOs for the dietary management of cows' milk allergy in infants less than 12 months of age.
- Trial name
- NCT04575298
- Testing
- Acceptability, tolerance study for an infant formula with human milk oligosaccharides
- Where
- United Kingdom
- Volunteers
- 10 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
Milk Hypersensitivity, Food Sensitivity
Evaluation of the Efficacy of a New Formula in Infants With Cow's Milk Protein Allergy
The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.
- Conditions
- Milk Hypersensitivity, Food Sensitivity, Protein Allergy
- Trial name
- Paradice (NCT01998074)
- Testing
- extensively hydrolyzed rice protein formula
- Where
- Belgium
- Sponsor
- United Pharmaceuticals