Clinical trials: Infant Formula, open to volunteers
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 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 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)
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
Gastrointestinal Tolerance, Gastrointestinal Symptoms
Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula
This randomized controlled double-blind study will compare the effect of a commercially available goat milk formula to a cow's milk formula on gastrointestinal symptoms and tolerance, and infections in infants.
- Conditions
- Gastrointestinal Tolerance, Gastrointestinal Symptoms, Infections, Quality of Life
- Trial name
- MESK-2 (NCT07342972)
- Testing
- Goat milk-based infant formula, Cow's milk-based infant formula
- Where
- Saudi Arabia
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Ausnutria Hyproca B.V.
Infant Nutritional Physiological Phenomena, Infant Formula
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
- Conditions
- Infant Nutritional Physiological Phenomena, Infant Formula, Infant Health, Infant Development
- Trial name
- NCT05868408
- Testing
- Control Formula, Experimental Formula 1, Experimental Formula 2
- Where
- 5 sites in Philippines, Saudi Arabia
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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
Cow's Milk Protein Allergy (CMPA)
Safety and Efficacy Evaluation of an Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy (CMPA)
This is a prospective, multi-center, randomized, open-label, active-controlled, parallel-group, non-inferiority study. The goal of this clinical trial is to evaluate the clinical efficacy and safety of an extensively hydrolyzed…
- Trial name
- NCT07484035
- Testing
- Feihe Extensively Hydrolyzed Formula, Nestlé Extensively Hydrolyzed Formula
- Where
- 6 sites in China
- Volunteers
- 124 people
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
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
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)
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 Growth
Growth and Health Efficacy of Novel Infant Formula : A Randomized Trial
Randomized, controlled study consisting of three parallel arms to investigate the effects of novel infant formula on growth, gut health, immune function, and sleep status in healthy infants and young children aged 12-18 months.
- Trial name
- NCT07534735
- Testing
- Investigational Formula 1, Investigational Formula 2
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Biostime (Changsha) Nutrition Foods Limited
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)
Functional Gastrointestinal Disorders
Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
This study aims to assess the evolution of functional gastrointestinal disorders (FGIDs) in infants fed with a new infant formula, using the Gastrointestinal (GI) and gastroesophageal reflux (GER) (GIGER) scale through an…
- Trial name
- NCT06488274
- Testing
- New infant formula
- Where
- 4 sites in France
- Volunteers
- 139 people
- Sponsor
- United Pharmaceuticals
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
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
Growth
Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)
This is a research study to compare an investigational infant formula against a currently marketed infant formula. An investigational infant formula is one that has never been approved by the United States Food and Drug…
- Trial name
- NCT07513506
- Testing
- Extensively hydrolyzed casein formula (C-eHCF), commercially available, Extensively hydrolyzed casein formula (INV-eHCF)
- Where
- 12 sites in United States
- Volunteers
- 214 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
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
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