Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06395571
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2024-04-26
Brief Title:
GI Symptoms in Infants Fed GMF or CMF
Sponsor:
Ausnutria Hyproca BV
Organization:
Ausnutria Hyproca BV
Study Overview
Official Title:
Common Gastrointestinal Symptoms in Healthy Infants Receiving Goat Milk-based Formula or Cow Milk-based Formula a Double-blind Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-04
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:
The aim of this study was to assess common gastrointestinal symptoms in healthy Brazilian infants receiving goat milk-based infant formula GMF compared to cows milk-based infant formula CMF during a 24 week intervention
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 double-blind randomized controlled trial gastrointestinal comfort in infants fed goat milk-based infant formula GMF or cows milk-based infant formula CMF was studied
Fifty-six healthy infants aged 3-12 months were followed for 24 weeks Stool consistency regurgitation frequency and crying duration were measured weekly using an adapted version of the Cows Milk-related Symptom Score CoMiSS where only the items for these scores were used Blood hemoglobin levels were measured at the start and at the end of the intervention
Fifty-six healthy infants aged 3-12 months were followed for 24 weeks Stool consistency regurgitation frequency and crying duration were measured weekly using an adapted version of the Cows Milk-related Symptom Score CoMiSS where only the items for these scores were used Blood hemoglobin levels were measured at the start and at the end of the 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