Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06301139
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2024-02-28
Brief Title:
Goat Milk Infant Formula Comfort Study
Sponsor:
Ausnutria Hyproca BV
Organization:
Ausnutria Hyproca BV
Study Overview
Official Title:
Clinical Trial to Assess Improvement of Digestive Symptoms With Goats Milk Infant Formula
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 cows 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 cows 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 cows mik based infant formula supplemented with probiotics lactobacillus reuteri drops CMFp The infants will be assessed by a local paediatricians using the Cows Milk-related Symptom Score CoMiSS This is a fast non-invasive and easy-to-use and validated questionnaire to assess infants reaction to proteins found in cows milk The higher the score the more sensitive the child is to cows 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None