Goat Milk Infant Formula Comfort Study

NCT ID: NCT06301139

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2024-02-01

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.

Conditions

Gastrointestinal Diseases; Cow's Milk Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Goat milk-based formula

goat milk-based infant formula (GMF)

Group Type: EXPERIMENTAL

Goat milk-based infant formula

Intervention Type: DIETARY_SUPPLEMENT

Infant formula based on goat milk for 4 weeks at volume depending on the infant

Cow's milk-based formula

cow's milk-based infant formula supplemented with probiotics (CMFp)

Group Type: PLACEBO_COMPARATOR

Cow's milk-based infant formula with probiotic drops

Intervention Type: DIETARY_SUPPLEMENT

Infant formula based on cow's milk with probiotic Lactobacillus reuteri drops for 4 weeks at volume depending on the infant

Interventions

Goat milk-based infant formula

Infant formula based on goat milk for 4 weeks at volume depending on the infant

Intervention Type: DIETARY_SUPPLEMENT

Cow's milk-based infant formula with probiotic drops

Infant formula based on cow's milk with probiotic Lactobacillus reuteri drops for 4 weeks at volume depending on the infant

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HM hospitales

UNKNOWN

Sponsor Role: collaborator

Ausnutria Hyproca B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alejandro López-Escobar, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario General de Villalba

Locations

HM hospitales

Madrid, , Spain

Countries

Spain

Other Identifiers

P17-004

Identifier Type: -

Identifier Source: org_study_id