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Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides
The primary objective of the study is to show that infants with cow milk protein allergy (CMPA) fed with a new FSMP infant formula with reduced level of protein & with 2 Human Milk Oligosaccharides (HMOs) (test formula) have a growth in line with infants fed with a comparable FSMP formula but without HMOs (control formula). The secondary objectives are to assess whether consumption of Test formula by CMPA infants (i) reduces medication use and risk for infections in particular lower respiratory tract infections/morbidity, (ii) is well tolerated and allows for age appropriate growth and (iii) reduces health care costs.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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|Eligible Ages||N/A - 6 Months|
Inclusion Criteria:1. Full term infant (37 weeks ≤ gestation ≤ 42 weeks) 2. 2500g ≤ birth weight ≤ 4500g 3. Written informed consent. 4. Infant aged between birth and 6 months. 5. Not being breastfed at time of enrollment or mothers of CMPA infant doing breastfeeding and independently elected before enrollment to exclusively formula feed. 6. Infants with physician diagnosed (and untreated with extensively hydrolysed or amino acid infant formula) Cow Milk Protein Allergy as per standard clinical practice and with at least 2 protocol specified symptoms present.
Exclusion Criteria:1. Prior treatment with extensively hydrolysed infant formula for more than 72 hours or with amino acid infant formula. 2. Congenital illness or malformation that may affect growth. 3. Demonstrated chronic malabsorption not due to CMPA. 4. Significant pre-natal and/or serious post-natal disease other than CMPA before enrollment (per investigator's medical decision). 5. Minor parent(s). 6. Infants whose parents or caregivers cannot be expected to comply with study procedures. 7. Currently participating or having participated in another clinical trial since birth.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
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The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Nestlé Health Science Spain|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Belgium, Hungary, Italy, Poland, Singapore, Spain, United Kingdom|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Cow's Milk Protein Allergy|
Infants with physician diagnosed CMPA, aged between birth and 6 months of age will take either the control or new test infant formula for 4 months and if judged suitable by physician, up to maximum of 12 months of age. Growth, adverse events, medication use and tolerance to formula will be assessed. As part of exploratory objectives, the study will also explore possible mode of action of the Test formula in CMPA infants, by assessing whether consumption of Test formula by CMPA infants affects stool microbiota and metabolic signatures as well as urine metabolic signatures and whether such changes can be associated to the intestinal inflammatory/health status, and the clinical measures.
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