Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides

Société des Produits Nestlé (SPN)194 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

194

Conditions

Cow's Milk Protein Allergy

Eligibility

Sex: ALLMax age: 6 Months

Medical Language ↔ Plain English

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.

Locations (42)

Cliniques Universitaires Saint Luc

Brussels, Belgium

University Hospital Brussels

Brussels, Belgium

CHC clinique de l'Esperance

Montegnée, Belgium

Clinexpert Gyogycentrum

Budapest, Hungary

Bagoly Egeszseghaz

Kecskemét, Hungary

Csolnoky Ferenc Korhaz

Outcomes

Primary Outcomes

Growth expressed as weight gain in grams per day

Body weight measured from enrollment to 4 months of study formula intake

Time frame: 4 months

Secondary Outcomes

Safety and medication use

Assessment of occurrence of adverse events (Number of adverse events per infant and number of infants with adverse events) and use of concomitant medication (specifically amount of antipyretics and antibiotics used per infant and number of infants using these) from enrollment until infants are 12 months of age.

Time frame: 12 months

Growth in terms of body weight.

Body weight (in kilograms) measured from enrollment until infants are 12 months of age.

Time frame: 12 months

Growth in terms of body length

Body length (in centimetres) measured from enrollment until infants are 12 months of age.

Time frame: 12 months

Growth in terms of head circumference

Head circumference (in centimetres) measured from enrollment until infants are 12 months of age.

Time frame: 12 months

Digestive tolerance and alleviation of CMPA

Recording of stool characteristics and frequency in diary, assessment of infant behavior pattern and medical assessment at each visit from enrollment until last study formula intake. Outcome will be reported as score on CoMiSS tool.

Time frame: 12 months

Compliance to study formula intake

Recording daily quantity consumed (in milliliters) in feeding diary for 3 days immediately before each visit from enrollment until last study formula intake.

Time frame: 12 months

Healthcare resource use assessed with Questionnaire

Questionnaire completed from enrollment until infants are 12 months of age.

Time frame: 12 months

Clinical Safety & Efficacy of a New Infant Formula With Specific Medical Purpose Containing Human Milk Oligosaccharides

Overview

Conditions

Interventions

Eligibility

Locations (42)

Outcomes

Primary Outcomes

Secondary Outcomes