Clinical trials: Infant Formula
Infant, Newborn
Comparative Gastrointestinal Tolerance of Various Infant Formulas in Healthy Term Infants
The objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental soy-based formulas, relative to a commercially available soy-based formula.
- Trial name
- NCT00798382
- Testing
- soy protein formula, Commercially available soy formula, Soy formula experimental #2
- Where
- 17 sites in United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Growth Failure, Congenital Heart Disease
A Study to Evaluate the Effects of a New Formula on the Growth, Safety and Tolerance of Infants With Growth Failure
This study is a prospective, open-label, multi-site, growth, safety and tolerance study to evaluate a NF (New Formula). A minimum of 45 evaluable infants with confirmed growth failure will be enrolled.
- Trial name
- NCT03563391
- Testing
- New Infant Formula
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Nutricia North America
Healthy Infants
Second Generation Human Milk Oligosaccharides Blend Study
The aim of this trial is to show that infants fed these new formulas, containing a blend of 5 Human Milk Oligosaccharides (HMOs), allow for growth in line with infants fed formulas without HMOs.
- Trial name
- NCT03722550
- Testing
- Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides, Breast-feeding, Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk
- Where
- 34 sites in Bulgaria, Hungary and 1 more
- Volunteers
- 789 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Diarrhea, Atopic Dermatitis
Cesarean Section Study
Effect, tolerance and safety of a supplementation with a probiotic on the risk of gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants born by Cesarean section.
- Trial name
- NCT01992497
- Testing
- Probiotic
- Where
- Germany
- Volunteers
- 721 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy Infants
HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants
The goal of this clinical trial is to learn how a mixture of human milk oligosaccharides impacts the development of the infant microbiota, the immune maturation and how the interaction between the microbiota and immune maturation…
- Trial name
- BELIEF (NCT06631937)
- Testing
- Human Milk Oligosaccharides
- Where
- 2 sites in Denmark
- Volunteers
- 334 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Healthy
Probiotic Formula and Infant Growth
This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life.
- Trial name
- NCT01476397
- Testing
- Control infant formula, Test infant formula
- Where
- 8 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infant Nutrition
Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health
In this study, the suitability of an infant formula with a modified content of protein and fatty acid pattern (LC-PUFA) for healthy term infants will be investigated.
- Trial name
- BEMIM (NCT01094080)
- Testing
- standard infant formula, modified infant formula, breast milk
- Where
- 2 sites in Germany, Serbia
- Volunteers
- 505 people, healthy volunteers welcome
- Sponsor
- Ludwig-Maximilians - University of Munich
Premature Infants
Effect of Vitamin D in Diets of Preterm Infants
Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation at birth. However, few data are available related to follow-up of infants receiving these formulas who were 28-34 weeks gestation at…
- Trial name
- NCT01698840
- Testing
- Vitamin D
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Baylor College of Medicine
Congenital Heart Disease
Effect of Feeding With Nutrient Dense Formula in Malnourished Infants and Children With Congenital Heart Defects
Infants with congenital heart disease (CHD) are usually born with a normal weight but develop malnutrition over time, and about 20-50% of these children are usually malnourished. Malnutrition in these patients is multifactorial.
- Trial name
- NCT04795076
- Testing
- Infant formula
- Where
- Iran
- Volunteers
- 65 people
- Sponsor
- Shahid Beheshti University
Gastro-Intestinal Tolerance
Term Infants Fed a Partially Hydrolyzed Whey Protein-Based Formula
To assess the effects of partially hydrolyzed whey protein-based infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants.
- Trial name
- NCT04934397
- Testing
- Study Infant Formula
- Where
- 14 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Infant Development
Gut Health,Feces Characteristics and Growth of Infants Fed With a New Infant Organic Formula
The goal of this clinical trial is to evauate the gut health, feces characteristics and growth of infants fed with a new study organic formula (investigational formula).
- Trial name
- NCT05695300
- Testing
- BLM ORGANIC GOLD+, BLM ORGANIC, Breast milk
- Where
- China
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Bellamy's Organic Pty Ltd
Growth, Infections
Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections
In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and…
- Trial name
- NCT06137235
- Testing
- cows milk infant formula and follow-on formula with bioactive ingredients, standard cows milk infant formula and follow-on formula
- Where
- 3 sites in Greece
- Volunteers
- 456 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina
Phenylketonuria, Inborn Errors of Metabolism
Evaluation of PKU Start
To evaluate the acceptability, tolerance and effect on metabolic control of PKU Start, a new Phe free protein substitute for the dietary management of PKU in infants from birth.
- Trial name
- PKU Start (NCT03058848)
- Testing
- PKU Start
- Where
- 3 sites in United Kingdom
- Volunteers
- 10 people
- Sponsor
- Vitaflo International, Ltd
Infant Development
European Childhood Obesity Project: Early Programming by Infant Nutrition?
Primary hypothesis to be tested: Early protein intake predicts infant growth and later risk of childhood obesity. Childhood obesity is a major public health problem and is an identified priority concern for the health care.
- Trial name
- CHOP (NCT00338689)
- Testing
- Lower protein formula; Higher protein formula
- Where
- 5 sites in Belgium, Germany and 3 more
- Volunteers
- 1,678 people, healthy volunteers welcome
- Sponsor
- Ludwig-Maximilians - University of Munich
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)
Obesity, Childhood
GI Tract Biomarkers in Infants With Different Diets
Childhood obesity is increasing with more than one-third of adolescents currently overweight and one in five with obesity. The lifelong incidence of obesity-related morbidities is also increasing with childhood obesity.
- Trial name
- NCT03751137
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Nemours Children's Clinic
Infant Formula Intolerance, Well-being
Efficacy of JINLINGGUAN and TOFER Formula in Formula-fed Chinese Term Infants
Objective：The present trial aimed to assess efficacy and safety of Jin Ling Guan and Tofer infant formula on body growth, intestinal tolerance, gut microbiota and fecal residual nutrients as compared to breast-milk in term…
- Trial name
- NCT03178474
- Testing
- JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®, TOFER Infant formula,TOFER®, Breast milk
- Where
- 3 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Sun Yat-sen University
Faltering Growth, Failure to Thrive
Leveraging Optimal Tolerance in Undernourished Infants to Support Growth
The goal of this study is to learn if InfaCore (IC) an energy and nutrient dense formulation (ENDF) can improve growth and tolerance in infants with or at risk of growth faltering when fed IC.
- Trial name
- LOTUS (NCT07549360)
- Testing
- Infant Formula
- Where
- Thailand
- Volunteers
- 35 people
- Sponsor
- Dutch Medical Food
Diabetes Mellitus, Type 1
Early Dietary Intervention and Later Signs of Beta-Cell Autoimmunity
The proposed mechanistic formula feeding study sets out to identify the mechanism(s) by which an extensively hydrolyzed casein formula is able to protect children at risk for type 1 diabetes (T1D) from beta-cell autoimmunity.
- Trial name
- EDIA (NCT01735123)
- Testing
- dietary intervention
- Where
- Finland
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- University of Helsinki
Infantile Colic
An Infant Formula Trial on Dietary Management of Infantile Colic
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.
- Trial name
- NCT03329222
- Testing
- Specific hydrolysed proteins, Standard cow's milk with prebiotics mixture
- Where
- 2 sites in Singapore, Thailand
- Volunteers
- 5 people
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.