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

Nestlé

Status: Completed

Conditions: Cow's Milk Protein Allergy

Treatments: Other: Test infant formula with HMOs; Other: Control infant formula without HMOs

Study type: Interventional

Funder types: Industry

Identifiers

NCT03085134

16.08.CLI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 194 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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194 participants in 2 patient groups

Test infant formula with HMOs

Experimental group

Description:

Extensively hydrolysed infant formula with HMOs taken by infant according to age, weight and appetite.

Treatment:

Other: Test infant formula with HMOs

Control infant formula without HMOs

Active Comparator group

Description:

Extensively hydrolysed infant formula without HMOs taken by infant according to age, weight and appetite

Treatment:

Other: Control infant formula without HMOs