Clinical trial NCT06301139: Goat Milk Infant Formula Comfort Study
Official title: Clinical Trial to Assess Improvement of Digestive Symptoms With Goat's Milk Infant Formula.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Diseases
Cow's Milk Intolerance
Lead sponsor: Ausnutria Hyproca B.V.
Sponsor class: INDUSTRY
Collaborators: name: HM hospitales
First posted: 2024-03-08
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled pilot study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cow's Milk-related Symptoms
timeFrame: 0-2 weeks
Secondary outcomes:
measure: Cow's Milk-related Symptoms
timeFrame: 0-4 weeks
measure: Parental stress
timeFrame: 0-4 weeks
measure: Parental quality of life
timeFrame: 0-4 weeks
measure: Weight
timeFrame: 0-4 weeks
measure: Length
timeFrame: 0-4 weeks
measure: Weight-for-age
timeFrame: 0-4 weeks
measure: Length-for-age
timeFrame: 0-4 weeks
measure: Weight-for-length
timeFrame: 0-4 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: HM hospitales
Study officials:
affiliation: Hospital Universitario General de Villalba
name: Alejandro López-Escobar, Dr.
role: PRINCIPAL_INVESTIGATOR
References: