Clinical trials: Infant Formula
Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity
SMASH: Study to Evaluate the Clinical Efficacy of an Extensively Hydrolysed Infant Formula With Synbiotics and a Human Milk Oligosaccharide (HMO) in Infants With Cow's Milk Protein Allergy (CMPA)
Cow's milk protein allergy (CMPA) is one of the most common food allergies in infants, with an estimated prevalence between 2% and 5%.
- Conditions
- Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity, Infant Nutrition Disorders, Gut Microbiota
- Trial name
- SMASH (NCT07342621)
- Where
- 13 sites in Spain
- Volunteers
- 41 people
- Sponsor
- Outcomes'10
Growth of Term Infants
The Effects on Growth and Tolerance of an Infant Formula Fed to Term Infants
This clinical trial will evaluate an investigational infant formula with a probiotic to determine if it provides normal growth and if it is well tolerated by term infants compared to a marketed routine infant formula.
- Trial name
- NCT01897922
- Testing
- An investigational infant formula containing a probiotic source, Control: Marketed routine infant formula
- Where
- 22 sites in United States
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Declarative Memory
The Effect of Feeding Infant Formula With Enriched Protein Fractions in the US
This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.
- Trial name
- NCT02433600
- Testing
- Cow's milk-based infant formula, Cow milk-based infant formula with enriched protein fractions
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Protein Allergy, Cow's Milk Protein Hypersensitivity
Efficacy of a New Thickened Extensively Hydrolyzed Formula
Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive hydrolysate.
- Trial name
- ALLAR (NCT01985607)
- Testing
- new extensively hydrolysed formula, Extensively hydrolysed formula
- Where
- 5 sites in Belgium, Greece and 3 more
- Volunteers
- 72 people
- Sponsor
- United Pharmaceuticals
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
Health of Formula-fed Children, Infant Infections in Formula-fed Children
Effect of Infant Formula With Bovine Lactoferrin and Low Iron Concentration on Infant Health and Immune Function
Breast milk is the gold standard of early infant nutrition and breastfed infants have advantages in several short and long term outcomes compared to those formula-fed.
- Conditions
- Health of Formula-fed Children, Infant Infections in Formula-fed Children, Iron Status of Formula-fed Children
- Trial name
- LIME (NCT02103205)
- Testing
- Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin, Formula with low iron concentration (2mg/L) without lactoferrin, Formula with normal iron concentration (8 mg/L) without lactoferrin
- Where
- Sweden
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- Umeå University
Very Preterm Infants
Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development
Preterm infants are especially vulnerable to gut microbiota disruption and dysbiosis since their early gut microbiota is less abundant and diverse.
- Trial name
- FEEDMI (NCT03663556)
- Testing
- Infant-feeding
- Where
- 2 sites in Portugal
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Universidade do Porto
Infant, Newborn
Tolerance of Healthy Term Infants Fed Infant Formulas
The objective of the study is to assess comparative gastrointestinal tolerance of normal term infants to various milk-protein infant formulas.
- Trial name
- NCT00705562
- Testing
- milk protein formulas, varying carbohydrate/protein sources
- Where
- 15 sites in United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Allergy, Cow's Milk Allergy
Hypoallergenicity of a New Formula in Subjects With Cow's Milk Allergy
Cow's milk protein allergy (CMA) is an immune-mediated reaction which can either be antibody-driven (IgE-mediated) or cell-mediated (non-IgE-mediated) or mixed, and elicits reactions which are reproducible upon re-exposure to…
- Trial name
- NIQA (NCT06134466)
- Testing
- Liquid Extensively hydrolyzed cow's milk protein infant formula
- Where
- Italy
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Federico II University
Focus on Healthy Infant Growth.
Infant Formula Supplemented With Probiotic Microorganisms and/or Prebiotic.
Evaluation the nutritional suitability of a based milk infant formula supplemented with friendly bacteria (probiotic microorganisms) and or nutritional fibers (prebiotic) to healthy, full term infants compare with an otherwise…
- Trial name
- NCT00836771
- Testing
- Infant Formula
- Where
- Israel
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Materna Laboratories
Growth
Study of Nutritional Suitability of a New Infant Formula for Term Infants
This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.
- Trial name
- NCT02490852
- Testing
- Investigational infant formula, Active Comparator: Commercially available Infant formula, Active Comparator: Human milk
- Where
- 18 sites in Austria, Croatia and 2 more
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Ausnutria Hyproca B.V.
Stool Composition
Stool Composition and Stool Characteristics in Healthy Term Infants Fed Human Milk or Infant Formulas
The primary efficacy objective was to determine and compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) among the feeding groups.
- Trial name
- NCT01861600
- Testing
- S-26 Gold, S-26 Gold EF1, S-26 Gold EF2
- Where
- Philippines
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Body Weight Changes
Clinical Trial of Infant Formula-fed
Compared with breast milk and another commercially available formula, infants' growth rate after 12 weeks' Friso formula with different ways of processing feeding will be assessed.
- Trial name
- NCT02715895
- Testing
- Friso, Wyeth, Breast milk
- Where
- 6 sites in China
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Maternal and Child Health Care Hospital of Hainan Province
Allergy, Asthma
Allergy and Asthma Following Children Who Were Fed Supplemented Infant Formula
Long-term cognitive outcome study of children who participated in randomized trials of LCP-supplemented formula during infancy.
- Trial name
- NCT00740974
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Healthy Term Infant
The Impact of a Novel Infant Formula on Immunity, Gut Health and Growth
The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months.
- Trial name
- NCT06686433
- Testing
- Novel infant formula, Standard infant formula
- Where
- 5 sites in China
- Volunteers
- 342 people, healthy volunteers welcome
- Sponsor
- Biostime (Guangzhou) Health Products Limited
Allergy
The Prolonged Effect of Consumption of a Partially Hydrolyzed Infant Formula During the First 6 Months of Life on the Development of Allergic Manifestations At 5 Years of Age
The present study is a 5-year follow-up of the Allergy Reduction Trial (A.R.T.) birth cohort study of 551 infants at high-risk for allergy. The A.R.T.
- Trial name
- NCT05418491
- Testing
- No intervention is used in the current study. Interventions were given in the original A.R.T. study
- Where
- 3 sites in Bulgaria, Cyprus and 1 more
- Volunteers
- 455 people
- Sponsor
- FrieslandCampina
Neonatal Abstinence Syndrome
RCT of High- vs. Standard-Calorie Formula for Methadone-Exposed Infants
Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy to implement and could improve early outcomes…
- Trial name
- NCT02178189
- Testing
- High Calorie Infant formula, Standard Calorie Infant Formula
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- University of Pittsburgh
Infant Feeding Behavior
The Bottle Study: Infant Weight Gain During Use of Novel Versus Typical Infant Feeding Bottles
The purpose of this study is to pilot test whether a novel infant feeding bottle changes how much formula an infant drinks and how quickly he/she drinks it, as compared to meals provided in a standard bottle.
- Trial name
- NCT01526018
- Testing
- Podee bottle
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Gastrointestinal Tolerance
Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula
The purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula.
- Trial name
- NCT03597113
- Where
- 46 sites in Turkey (Türkiye)
- Volunteers
- 320 people
- Sponsor
- Abbott Nutrition
Growth Failure
Safety Study of Infant Formula With Partially Hydrolized Whey
The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color.
- Trial name
- NCT00548106
- Testing
- partially hydrolyzed whey, Nan HA
- Where
- Israel
- Sponsor
- Soroka University Medical Center