NCT06301139

Goat Milk Infant Formula Comfort Study

Clinical Trial to Assess Improvement of Digestive Symptoms With Goat's Milk Infant Formula.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Ausnutria Hyproca B.V. · Industry
• Sex: All
• Age: 6 Weeks – 3 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Goat milk-based infant formula	Infant formula based on goat milk for 4 weeks at volume depending on the infant
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

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-04-01
• Completion: 2024-02-01
• First posted: 2024-03-08
• Last updated: 2024-03-08

Locations

1 site across 1 country: Spain