Goat Milk Infant Formula Comfort Study

Ausnutria Hyproca

Status

Completed

Conditions

Cow's Milk Intolerance

Gastrointestinal Diseases

Treatments

Dietary Supplement: Goat milk-based infant formula

Dietary Supplement: Cow's milk-based infant formula with probiotic drops

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06301139

P17-004

Details and patient eligibility

About

In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops.

Full description

Anecdotal evidence shows that the use of goat milk-based infant formula decreases discomfort of infants with cow's milk related symptoms. In this randomized controlled pilot study, the effect on comfort during usage of goat-milk based infant formula is studied. Twenty formula fed infants (aged between 6 weeks and 3 months) who experience mild discomfort will receive goat milk-based infant formula (GMF) or cow's mik based infant formula supplemented with probiotics lactobacillus reuteri drops (CMFp). The infants will be assessed by a local paediatricians using the Cow's Milk-related Symptom Score (CoMiSS). This is a fast, non-invasive and easy-to-use and validated questionnaire to assess infant's reaction to proteins found in cow's milk. The higher the score, the more sensitive the child is to cow's milk proteins, the maximum score is 33 points. Infants with a CoMiSS Score between 6 and 12 will be enrolled in this study. It is expected that infants will have a better response to GMF, which will result in a decrease of the CoMiSS Score after a 2 weeks intervention.

Enrollment

18 patients

Sex

All

Ages

6 weeks to 3 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy full-term infant with birth weight ≥2,500 to ≤4,500 g
Infant aged between 4 weeks and 3 months at enrolment
CoMiSS value at baseline between 6 and 12
Infant is exclusively bottle fed with cow's milk based infant formula at baseline

Exclusion criteria

Breastfed infants
Congenital illness or malformation that may affect infant feeding or normal growth
Gastrointestinal disorders
Confirmed cow or goat milk protein allergy or lactose intolerance
Supplemental feeding
Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrolment
Infant participating in another clinical study