Clinical trials: Infant Formula, open to volunteers
Healthy Infants
Efficacy of Two HMOs in Chinese Infants
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier…
- Trial name
- NCT06361719
- Testing
- Experimental Group (EG), Control Group (CG)
- Where
- China
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Cow Milk Protein Allergy
Growth And Safety Outcomes In Infants With Cow´s Milk Protein Allergy (CMPA) Fed A Novel Extensively Hydrolyzed Formula (eHF)
Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula.
- Trial name
- NCT07711938
- Testing
- New generation eHF, Commercial eHF
- Volunteers
- 410 people
- Sponsor
- Société des Produits Nestlé (SPN)
Cow's Milk Allergy
Infant Formula in Infants and Children With Cow's Milk Allergy
This is a multi-center, randomized, double-blinded, placebo-controlled food challenge to be conducted in infants and children with confirmed IgE-mediated cow's milk allergy (CMA), followed by a 7-day open feeding of the…
- Trial name
- NCT06456541
- Testing
- Experimental Extensively Hydrolyzed Formula
- Where
- 9 sites in United States
- Volunteers
- 96 people
- Sponsor
- Abbott Nutrition
Functional Gastrointestinal Disorders (FGIDs), Infant Discomfort
Effects of Goat Milk Formula on Gastrointestinal Comfort and Growth in Infants
Infant gastrointestinal discomfort is common in early life and can affect feeding, sleep, and overall well-being. Goat milk formula, due to its unique protein composition and smaller fat globules, may be easier to digest and…
- Trial name
- NCT07778927
- Testing
- Goat Milk Formula, Cow Milk Formula
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Ruijin Hospital
Nutrition of Ileostomy Infants
Enteral Nutrition in Infants With Ileostomy
This study is a prospective, single center, practical, and observational open clinical study.
- Trial name
- NCT04707443
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Children's Hospital of Fudan University
Infant ALL
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
The goal of this clinical trial is to study growth (weight gain per day) in healthy full-term infants who consume the investigational infant formula containing beneficial ingredients against infants consuming a control infant…
- Trial name
- NCT07867509
- Testing
- Infant Formula, Breastfeeding
- Volunteers
- 387 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina
Gastroesophageal Reflux in Children
Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.
- Trial name
- STELLAR (NCT04358146)
- Testing
- Experimental Infant formula, Infant formula thickened with locust bean gum
- Where
- 12 sites in Belgium, France and 2 more
- Volunteers
- 346 people
- Sponsor
- United Pharmaceuticals
Healthy Term Infants
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
The goal of this interventional clinical trial is to compare the growth parameters of healthy term infants fed either a new experimental rice hydrolyzed rice protein-based formula or a control formula (standard cow's milk…
- Trial name
- RIGA (NCT07686224)
- Testing
- Rice formula (New formula based on hydrolysed rice proteins), Control formula (Standard cow's milk proteins-based formula)
- Where
- 10 sites in France
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Health and Happiness Research Limited
Healthy Infants
Efficacy of a New Infant Formula Composition on Gut Health in Infants
The aim of this study is to investigate potential health benefits of the experimental formula. The main objective is whether the experimental formula elevates the relative abundance of Bifidobacterium in stool samples after 10…
- Trial name
- NCT07242508
- Testing
- Infant Formula, Infant Formula with bioactive ingredients
- Where
- Bulgaria
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- FrieslandCampina
Infant Colic, Atopic Dermatitis
Use of Bifidobacterium Bifidum in Formula-Fed Infants With Colic, With or Without Atopic Dermatitis
The goal of this clinical trial is to evaluate whether daily probiotic supplementation with Bifidobacterium bifidum (Bifipral® drops) can reduce crying time in formula-fed infants aged 5 months or younger diagnosed with infant…
- Trial name
- NCT07754968
- Testing
- Bifidobacterium bifidum BFP19® and BFP29® (Bifipral®)
- Where
- Italy
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Roma La Sapienza
Atopic Dermatitis (AD)
Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy.
- Trial name
- SPHINX (NCT06943469)
- Testing
- Test formula, Control formula
- Where
- 25 sites in Belgium, France and 3 more
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
Malnutrition (Calorie), Infant Nutrition Disorder
Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis
The goal of this clinical trial is to learn if Goat Milk-Derived Formula Alternatives (GMDFA) are safe and effective for infants who are unable to be exclusively breastfed.
- Conditions
- Malnutrition (Calorie), Infant Nutrition Disorder, Growth Flatering, Gut Microbiome
- Trial name
- GMDFA (NCT07225153)
- Testing
- GMDFA, Undiluted Goat Milk
- Where
- Pakistan
- Volunteers
- 15 people
- Sponsor
- Aga Khan University
Infant Body Composition and Metabolism, Metabolism
Studying Phenotypic Risks for Obesity and Underlying Traits in Young Infants
The purpose of this research study is to understand how infants metabolize different meals and to develop clinical tools which identify infants as having two different phenotypes.
- Conditions
- Infant Body Composition and Metabolism, Metabolism, Energy Expenditure, Infant Formula
- Trial name
- SPROUT (NCT07096011)
- Testing
- Meal Test - Human Milk, Meal Test - Infant Formula
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
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
Childhood Obesity
Josef Ressel Centre Perinatal Programming
Background: Metabolic imprinting through early childhood nutrition seems to play an important role in the aetiology of obesity. Overweight at age two and later in life is associated with excessive weight gain as early as three…
- Trial name
- JRP (NCT03634930)
- Testing
- observation
- Where
- Austria
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Moenie van der Kleyn
Weight Gain
Growth of Preterm Infants Fed a Infant Milk Formula Containing High Versus Low Amounts of Beta-palmitate
The aim of this study is to assess weight gain of preterm infants (gestational age lower than 32 weeks) fed infant milk formula with about 60% beta-palmitate (EX_IMF) vs infant milk formula with similar macronutrient, mineral and…
- Trial name
- NCT04541095
- Testing
- EX_IMF, ST_IMF
- Where
- 2 sites in Italy
- Volunteers
- 150 people
- Sponsor
- Ospedali Riuniti Ancona
Gastric Emptying
Gastric Emptying in Neonates and Infants After Formula Feeding
Ultrasound imaging will be used to evaluate time for gastric emptying in healthy, fasting newborns, and infants following feeding of clear liquids and/or milk (including breast or formula).
- Trial name
- NCT02665923
- Testing
- Gastric ultrasound
- Where
- United States
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Columbia University
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
GERD in Infants
GERD Infant Feeding Therapeutics Trial (GIFT Trial)
The goal of this investigator-initiated, single-center, randomized controlled trial (RCT) is to compare the effects of four weeks of three therapies on clinical and mechanistic outcomes based on pH-Imp testing using a three-arm…
- Trial name
- GIFT (NCT06114836)
- Testing
- Omeprazole, AR formula
- Where
- United States
- Volunteers
- 369 people
- Sponsor
- Nationwide Children's Hospital