Clinical trials: sponsored by Nutricia Research
- Lead sponsor (exact) Nutricia Research
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
To demonstrate growth equivalence of a Baby formula Test Product when compared to the Control product after 16 weeks. And to demonstrate better neurocognitive development at 52 weeks post-baseline in subjects receiving the Test…
- Trial name
- GAIA (NCT06475521)
- Testing
- Infant Formula
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 579 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Complex Conditions, Including Impairment of the GI Tract
Neocate In Infants and Children With Complex Conditions
Infants and young children up to 10 years of age with a complex condition involving the gastrointestinal tract are at risk of poor nutritional status, including faltering growth.
- Trial name
- NICC (NCT04265729)
- Testing
- Neocate Infant and Junior marketed products
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 13 people
- Sponsor
- Nutricia Research
Follow-on Formula, Infant
Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.
This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will…
- Conditions
- Follow-on Formula, Infant, Faeces, Gut Microbiota
- Trial name
- FUNTASTIC (NCT07207109)
- Testing
- Test: Follow-on formula with synbiotics, Control: Regular follow-on formula
- Where
- 2 sites in Indonesia
- Volunteers
- 268 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Iron Status
Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.
This study evaluates the effect of young child formula in children 1-3 years of age. Subjects will receive either test or control product.
- Trial name
- NCT07324135
- Testing
- Nutritional product
- Where
- Indonesia
- Volunteers
- 466 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Infant
A Real-world Evidence (RWE) Study to Assess Infant Stool Consistency in France
The objective of this study is to investigate the influence of various factors (e.g. diet) on the stool consistency of infants in France.
- Trial name
- Popodata (NCT07745413)
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Length, Weight
A Growth Artificial Intelligence Algorithm for leNgth and Weight Study
This is a data collection and machine learning accuracy testing project that aims to a) collect training data to enhance, by machine learning, an artificial intelligence (AI) algorithm for measuring length in infants and young…
- Trial name
- GAINS (NCT06920550)
- Where
- 4 sites in Netherlands, Poland and 1 more
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Cow Milk Allergy
Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula
This is a single arm, open label, multicenter intervention trial to evaluate growth parameters, cow's milk related symptoms, gastrointestinal tolerance and safety in infants with cow's milk allergy receiving a hydrolyzed protein…
- Trial name
- STORY (NCT05618704)
- Testing
- Hydrolyzed protein infant formula
- Where
- Poland
- Volunteers
- 69 people
- Sponsor
- Nutricia Research
Subjects in Need of a Human Milk Fortifier (HMF), Growth
Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.
Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment.
- Conditions
- Subjects in Need of a Human Milk Fortifier (HMF), Growth, Tolerance, Safety
- Trial name
- Renoir (NCT03315221)
- Testing
- Test product, Control product
- Where
- 15 sites in France, Germany and 2 more
- Volunteers
- 207 people
- Sponsor
- Nutricia Research
Cow's Milk Allergy
Hypoallergenicity of a Hydrolyzed Protein Infant Formula
Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.
- Trial name
- HYPO STORY (NCT05731206)
- Testing
- Hydrolyzed protein infant formula, commercially available hypoallergenic infant formula
- Where
- Italy
- Volunteers
- 29 people
- Sponsor
- Nutricia Research
Allergy, Infections
A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life
This is a follow-up study of a randomised clinical trial, called TEMPO (a double-blind randomized clinical trial investigating infant formula and human breast milk consumption), in which infants participated in their first year…
- Trial name
- NCT05449756
- Testing
- Self-administered questionnaires
- Where
- Netherlands
- Volunteers
- 705 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Infant Growth, Parent and Infant User Experience
Observational Study of Infants Fed With Dairy and Plant Based Infant Formula
A study to assess and evaluate adequate growth in infants receiving a dairy and plant based infant formula in a real-world setting, and parents' and infants' experiences with this infant formula.
- Trial name
- Complement (NCT05804214)
- Testing
- Dairy and plant based infant formula feeding
- Where
- Netherlands
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Regurgitation, Gastric, Diarrhea
To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation
A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)
- Trial name
- Solar (NCT04042454)
- Testing
- milk based anti-regurgitation infant formula, Milk based infant formula
- Where
- 16 sites in Italy, Poland and 1 more
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Phenylketonuria (PKU)
PANDA: PKU Amino Acid Evaluation
Phenylketonuria (PKU) is a rare inherited metabolic disorder, where subjects are born with a genetic deficiency in the phenylalanine hydroxylase enzyme (PAH), which leaves them unable to convert Phenylalanine (Phe) into Tyrosine…
- Trial name
- PANDA (NCT04086511)
- Where
- 2 sites in Belgium, United Kingdom
- Volunteers
- 37 people
- Sponsor
- Nutricia Research
Healthy Young Children
An Evaluation of the Tolerability and Acceptability of a New Plant-based Formula for Young Children
An evaluation of the tolerability and acceptability of a new plant-based formula in 45 healthy young children
- Trial name
- NCT05265156
- Testing
- Plant based formula for children aged between 12 and 36 months
- Where
- Indonesia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Gastrointestinal Tolerance
Gastrointestinal Tolerance and Safety of an Infant Formula Containing Prebiotics, Probiotics and Postbiotics.
A study to investigate the gastrointestinal tolerance and safety of a new formula containing prebiotics, probiotics and postbiotics.
- Trial name
- TREE (NCT04745455)
- Testing
- Infant formula containing prebiotics, probiotics and postbiotics
- Where
- 3 sites in Poland
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Regurgitation, Gastric
Evaluation of the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula
A randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum in infants with regurgitation.
- Trial name
- Leopard (NCT03371615)
- Testing
- Anti-regurgitation infant formula
- Where
- 2 sites in Poland
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Immunity
A Clinical Study to Investigate the Effect of a Partially Hydrolysed Infant Formula With Added Synbiotics on the Development of Allergic Manifestations in Infants at High Risk of Developing Allergy
With the rising prevalence of allergic diseases and the subsequent risk of developing other immune-related disorders, primary prevention of allergy has become a major priority.
- Trial name
- MAESTRO (NCT03062995)
- Testing
- Infant Formula with added synbiotics, Standard Infant formula
- Volunteers
- healthy volunteers welcome
- Sponsor
- Nutricia Research
Healthy Term Infants
Randomised, Controlled Study to Assess Safety and Tolerance of Infant Formula With Prebiotics and Postbiotics in Healthy Infants.
A randomised, controlled, double-blind, parallel group, multi-country study to investigate the safety and tolerance of infant formula with prebiotics and postbiotics in healthy term infants.
- Trial name
- WAVE (NCT04015050)
- Testing
- milk based infant formula
- Where
- Poland
- Volunteers
- 279 people, healthy volunteers welcome
- Sponsor
- Nutricia Research
Phenylketonurias
Effects of Synergy on Nutrient Intake and Acceptability in Phenylketonuria (PKU)
Phenylketonuria (PKU) is a rare inherited metabolic disorder, where subjects are born with a genetic deficiency in the phenylalanine hydroxylase enzyme (PAH), which leaves them unable to convert Phenylalanine (Phe) into Tyrosine…
- Trial name
- ESSENTIAL (NCT03777826)
- Testing
- PKU Synergy
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 13 people
- Sponsor
- Nutricia Research
Urea Cycle Disorder, Inborn Errors of Metabolism
A Collection of Case Studies in Infants With UCD to Evaluate Infant Growth and the Safety of a New Medical Food for UCD
Original study: Study aims to enroll 3-5 children with confirmed Urinary Cycle Disorder (UCD). Subjects meeting the inclusion and exclusion criteria are included during the baseline visit.
- Trial name
- NCT03911089
- Testing
- UCD Anamix Infant
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Nutricia Research