Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
Study NCT ID:
NCT06708559
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2024-11-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants
Sponsor:
Société des Produits Nestlé (SPN)
Organization:
Study Overview
Official Title:
Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants: A Prospective, Observational Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
This will be a prospective observational study aiming to investigate immune health biomarkers and fecal microbiota in 48-60 Filipino breastfed infants from birth to 12 months of age. An optional follow-up period of approximately 2 years will follow.
Detailed Description:
This will be a prospective observational study in healthy term infants who are exclusively breastfed. Approximately 48-60 healthy breastfed infants aged ≥14 to ≤35 days at enrollment will be recruited and followed up until 12 month of age at 6 on-site visits: V1 (baseline), V3 (2 months), V5 (4 months), V6 (6 month), V7 (10months) and V8 (12 months).
The 12-month observational period will be followed by a 2year optional follow-up period for a total duration of the study of approximately 3 years.
The primary objective of this clinical study is to characterize early immune system development in breastfed Filipino infants by investigating infant blood markers of systemic immunity.
The secondary objectives will include the characterization of infant fecal markers of immune health and gut barrier function, infant blood and fecal microbiome, interactions between immune development and microbiome maturation, infant fecal metabolic profile and fecal pH, infant gastrointestinal (GI) tolerance, infant anthropometric measurements, infant complementary food intake as well as infant illness and infection.
The 12-month observational period will be followed by a 2year optional follow-up period for a total duration of the study of approximately 3 years.
The primary objective of this clinical study is to characterize early immune system development in breastfed Filipino infants by investigating infant blood markers of systemic immunity.
The secondary objectives will include the characterization of infant fecal markers of immune health and gut barrier function, infant blood and fecal microbiome, interactions between immune development and microbiome maturation, infant fecal metabolic profile and fecal pH, infant gastrointestinal (GI) tolerance, infant anthropometric measurements, infant complementary food intake as well as infant illness and infection.
Study Oversight
Has Oversight DMC:
False
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?: