Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose (FSMP) Containing 2 Human Milk Oligosaccharides (HMOs)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 194
- Locations
- 42
- Primary Endpoint
- Growth expressed as weight gain in grams per day
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
- •2500g ≤ birth weight ≤ 4500g
- •Written informed consent.
- •Infant aged between birth and 6 months.
- •Not being breastfed at time of enrollment or mothers of CMPA infant doing breastfeeding and independently elected before enrollment to exclusively formula feed.
- •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
- •Prior treatment with extensively hydrolysed infant formula for more than 72 hours or with amino acid infant formula.
- •Congenital illness or malformation that may affect growth.
- •Demonstrated chronic malabsorption not due to CMPA.
- •Significant pre-natal and/or serious post-natal disease other than CMPA before enrollment (per investigator's medical decision).
- •Minor parent(s).
- •Infants whose parents or caregivers cannot be expected to comply with study procedures.
- •Currently participating or having participated in another clinical trial since birth.
Arms & Interventions
Test infant formula with HMOs
Extensively hydrolysed infant formula with HMOs taken by infant according to age, weight and appetite.
Intervention: Test infant formula with HMOs (Other)
Control infant formula without HMOs
Extensively hydrolysed infant formula without HMOs taken by infant according to age, weight and appetite
Intervention: Control infant formula without HMOs (Other)
Outcomes
Primary Outcomes
Growth expressed as weight gain in grams per day
Time Frame: 4 months
Body weight measured from enrollment to 4 months of study formula intake
Secondary Outcomes
- Safety and medication use(12 months)
- Compliance to study formula intake(12 months)
- Growth in terms of body length(12 months)
- Growth in terms of head circumference(12 months)
- Digestive tolerance and alleviation of CMPA(12 months)
- Healthcare resource use assessed with Questionnaire(12 months)
- Growth in terms of body weight.(12 months)