NCT06708559

Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants

Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants: A Prospective, Observational Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 14 Days – 35 Days
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Breast-fed infants	Immune system characterization via blood and stool samples collection

Timeline

• Start date: 2024-11-29
• Primary completion: 2026-01-30
• Completion: 2026-08-31
• First posted: 2024-11-27
• Last updated: 2026-04-03

Locations

1 site across 1 country: Philippines