Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants

NCT06708559 | Active Not Recruiting

• 1 other identifier: 2313INF
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Immune system; Breastfeeding

Outcome Measures

Primary Outcomes (1)

• Markers of systemic immunity

  Descriptive statistics of plasma immune proteomics using mass cytometry or immunoassays, and vaccine-specific antibodies assessed by ELISA

  Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months and 12months

Secondary Outcomes (12)

• Fecal markers of immune health and gut barrier

  Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12 months

• Infant fecal microbiome

  Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12months

• Fecal metabolic profile and pH

  Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12 months

• Plasma Metabolomics

  Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, and 12 months

• GI Tolerance

  Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months

Other Outcomes (2)

• Incidence of Adverse Events

  From infant age ≥14 to ≤35 days to 12 months

• Concomitant medications and treatments

  From infant age ≥14 to ≤35 days to 12 months

Interventions

Breast-fed infants OTHER

Immune system characterization via blood and stool samples collection

Eligibility Criteria

• Age: 14 Days - 35 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 60 healthy breastfed infants aged ≥14 to ≤35 days at enrollment. To ensure balanced sex representation of the study population, approximately 30 males and 30 females will be enrolled in the study.

You may qualify if:

• Written informed consent is obtained from parent(s)/ legally authorized representative(s) (LAR(s)).
• Parent(s)/ LAR(s) must be able to provide evidence of parental authority and identity.
• Parents/ LARs must understand the informed consent and other study documents.
• Infants whose parent(s)/ LAR (s) has consented to blood collection as per protocol.
• Able to temporarily store stool samples in a household freezer.
• Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits, and the requirements of the study protocol.
• Infants whose parent(s)/LAR(s) can be contacted directly by telephone throughout the study.
• Healthy term infant (≥37 weeks of gestation)
• At enrollment visit, postnatal age ≥14 to ≤35 days (date of birth = day 0)
• Birth weight is appropriate for gestational age (i.e., ≥ 2500g and ≤ 4500g)
• Infant has exclusively received breastmilk from birth to enrollment, and parent intends to continue exclusive breastmilk feeding until infant age 6 months.

You may not qualify if:

• A medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
• Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
• Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
• Presently receiving or have received prior to enrolment any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool microbiota and characteristics (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g., insulin or growth hormone); gastric acid secretion.
• Infants whose parent(s) has(ve) not reached legal age of majority (18 years old) upon enrollment.
• Currently participating or having participated in any interventional clinical trials since birth.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Asian Hospital and Medical Center, Muntinlupa City, Philippines: collaborator

Study Sites (1)

Asian Hospital and Medical Center

Manila, 1780, Philippines

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood \& stool

MeSH Terms

Conditions

Breast Feeding

Interventions

Lactation

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Maria Rosario JK Capeding, MD

  Asian Hospital and Medical Center, Philippines

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 27, 2024
• Study Start: November 29, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)