Clinical trials: Breast Milk
Allergy
Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed formula with an added probiotic in children with documented milk allergy.
- Trial name
- NCT01181297
- Testing
- Extensively Hydrolyzed Formula with a Probiotic, Extensively Hydrolyzed Formula without a Probiotic
- Where
- 2 sites in Italy, Netherlands
- Sponsor
- Mead Johnson Nutrition
Immune Function, Immunity
Effects of TM02® Supplementation on Immune Function in Children
This randomized, double-blind, placebo-controlled clinical study evaluated the effects of 12 weeks of TM02® supplementation on immune-related outcomes in generally healthy children aged 2 to 12 years.
- Trial name
- NCT07853573
- Testing
- TM02®
- Where
- Malaysia
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Ligno Biotech Sdn. Bhd.
Formula Feeding of Healthy Full Term Infants, Breast Feeding of Healthy Full Term Infants
Impact of Infant Feeding on Newborn Metabolomic Profile
The purpose of this study is the evaluation with untargeted modalities, of the urine metabolomic profile in a group of infants fed with a standard formula, a group of infants fed with a formula supplemented with functional…
- Trial name
- NCT01606683
- Testing
- Infant formula with GOS, beta-palmitate, acidified milk, Standard infant formula without functional ingredients, No intervention
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Heinz Italia SpA
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
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
Focus of Study is Healthy Chinese Lactating Mother 0-270 Days
Evaluation of the Nutrients Composition of Breast Milk of Chinese Lactating Mothers and Their Nutrition Intake
To understand breast milk composition during different lactating stages.
- Trial name
- MING (NCT01971671)
- Testing
- no intervention.
- Where
- China
- Volunteers
- 560 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Infant Development
Metabolomic Profile of Urine Samples From Neonates Fed With Breast Milk and an Infant Formula Enriched With Synbiotics
The aim of this trial is to verify - based on metabolomics and other anthropometric parameters - whether exclusive nutrition of infant formula enriched with synbiotics (probiotics B.lactis and prebiotics FOS), Long-Chain…
- Trial name
- mtburnIFsynb (NCT03320837)
- Testing
- Infant formula, Breast milk
- Where
- Greece
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Rontis Hellas SA
Growth, Tolerance
Human Milk Oligosaccharides (HMOs) - Post Marketing Study on Infants (NeHMO)
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT).
- Conditions
- Growth, Tolerance, Adverse Event
- Trial name
- NCT07302477
- Testing
- HMO Supplemented Infant Formula
- Where
- 4 sites in Pakistan
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy
A Study of the Impact of Different Delivery Modes on Specific Macronutrient Components in Human Milk
The aim of the study is to evaluate the impact of different delivery modes on specific macronutrient components in human milk.
- Trial name
- ZoomMING (NCT05516940)
- Where
- China
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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.
Healthy Children
Study to Evaluate the Effects of a Formula on the Gut Health of Healthy Chinese Infants and Young Children
The infant gut microbiota, a major driver of the maturation of the immune system, is formed through the successive establishment and development during infancy and early childhood.
- Trial name
- NCT04864665
- Testing
- a formula with prebiotics and milk fat
- Where
- 6 sites in China
- Volunteers
- 455 people, healthy volunteers welcome
- Sponsor
- Danone Nutricia
Cow's Milk Protein Allergy
The Journey of Children With Cow's Milk Protein Allergy in Mexico.
To gain insights on the application, use and effectiveness of Frisolac Gold Intensive HA and Frisolac Gold PEP AC with reference to improvement of CMPA symptoms and to determine the methodology used by Mexican Health Care…
- Trial name
- Friso02 (NCT04596059)
- Testing
- Frisolac Gold Intensive HA
- Where
- 4 sites in Mexico
- Volunteers
- 79 people
- Sponsor
- FrieslandCampina
Replacement Therapy in Preterm Infants
Efficacy and Safety of Bile Salt Stimulated Lipase (BSSL) as Replacement Therapy in Pasteurized Breast Milk for Preterm Infants
The purpose of this study is to evaluate the efficacy in preterm infants following treatment with BSSL when administered in pasteurized breast milk.
- Trial name
- NCT00659243
- Testing
- rhBSSL
- Where
- 8 sites in France, Italy
- Volunteers
- 32 people
- Sponsor
- Swedish Orphan Biovitrum
Low-Birth-Weight Infant, Premature Infants
Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants
An observational and prospective study involving about 30 healthy lactating mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and who can provide enough maternal milk (3mL) to be…
- Trial name
- MISTU (NCT02971904)
- Testing
- human milk collection
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Danone Early Life Nutrition Brazil
Healthy
Effect of a Multinutrient-Optimized Infant Formula Supplemented With Human Milk Oligosaccharides on Infant Growth and Development: A Multicenter, Randomized, Controlled Trial
This study aims to learn about a newly developed infant formula that adds two special ingredients found in breast milk (human milk oligosaccharides, HMOs) and improves other nutrients.
- Trial name
- NCT06569797
- Testing
- Human Milk Oligosaccharide-Supplemented, Multi-Nutrient Optimized Infant Formula, Commercially Available Standard Formula, Breast Milk Feeding
- Where
- 6 sites in China
- Volunteers
- 240 people, healthy volunteers welcome
- 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
Milk Hypersensitivity
Amino Acid Feed Children's Study
This study of the tolerance and acceptability of an amino acid based feed will assess gastrointestinal (GI) tolerance, product intake and acceptability in relation to taste, smell, texture in 20 patients between 1-10 years…
- Trial name
- NCT02569840
- Testing
- Amino Acid Feed
- Volunteers
- 30 people
- Sponsor
- Nutricia UK Ltd
Allergy
Acceptability and Palatability Study of Paediatric Amino Acid Feed
Product acceptability and palatability data from a minimum of 15 participants are required to submit an application to the Advisory Committee on Borderline Substances (ACBS) and the Health Service Executive (HSE) for Ireland for…
- Trial name
- NCT06547346
- Testing
- Alfamino Junior
- Where
- United Kingdom
- Volunteers
- 15 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
Cow's Milk Allergy
Evaluation of Hypoallergenicity 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
- NCT02450643
- Testing
- Test extensively hydrolyzed formula, Control extensively hydrolyzed formula
- Where
- 8 sites in United States
- Volunteers
- 83 people
- Sponsor
- Société des Produits Nestlé (SPN)