Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Breast-fed infants

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Philippines
  • Manila, Philippines, 1780
    • Asian Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

1. Written informed consent is obtained from parent(s)/ legally authorized representative(s) (LAR(s)).
2. Parent(s)/ LAR(s) must be able to provide evidence of parental authority and identity.
3. Parents/ LARs must understand the informed consent and other study documents.
4. Infants whose parent(s)/ LAR (s) has consented to blood collection as per protocol.
5. Able to temporarily store stool samples in a household freezer.
6. Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits, and the requirements of the study protocol.
7. Infants whose parent(s)/LAR(s) can be contacted directly by telephone throughout the study.

8. Infants must meet all the following inclusion criteria to be eligible for enrollment into the study:

   1. Healthy term infant (≥37 weeks of gestation)
   2. At enrollment visit, postnatal age ≥14 to ≤35 days (date of birth = day 0)
   3. Birth weight is appropriate for gestational age (i.e., ≥ 2500g and ≤ 4500g)
   4. Infant has exclusively received breastmilk from birth to enrollment, and parent intends to continue exclusive breastmilk feeding until infant age 6 months.

Exclusion Criteria:

1. A medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:

   1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
   2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
   3. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study. Of note, children who are normally healthy but at the time of enrolment suffering from acute illness in a minor condition which are common in childhood and do not require some of the exclusionary medication mentioned below can be enrolled.
2. 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.
3. Infants whose parent(s) has(ve) not reached legal age of majority (18 years old) upon enrollment.
4. Currently participating or having participated in any interventional clinical trials since birth.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant illness and infection	Descriptive data and overall score derived from the Pediatric Immune System Index Questionnaire completed by parents	Infant age 6 months
Long-term infant illness (during the optional follow-up)	Descriptive data from the Infant Illness Questionnaire completed by parents	Infant age 12 months, 18 months, 24 months, 30 months, and 36 months
Fecal markers of immune health and gut barrier	Fecal markers of immune health and gut barrier, such as but not restricted to calprotectin and α-1-antitrypsin assessed by ELISA or alternative methods; Fecal cytokine profile using multiplex assays	Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12 months
Infant fecal microbiome	Microbiota composition, diversity, community types, and abundance of bacteria taxa	Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12months
Fecal metabolic profile and pH	pH and fecal organic acids, such as lactate, propionate, butyrate, acetate, valerate and total fecal organic acids, in wet stool weight and per dry stool weight	Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, 10 months and 12 months
Plasma Metabolomics	Untargeted Plasma metabolomics Analyses	Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months, and 12 months
GI Tolerance	Stool frequency and consistency, GI symptoms and GI-related behaviors collected via 1-day and 3-day GI Symptom and Behavior Diaries; GI burden score derived from the Infant Gastrointestinal Symptom Questionnaire (IGSQ-13)	Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
Weight	Measurement of weight in grams	Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
Length	Measurement of length in cm	Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
Head circumference	Measurement of head circumference in cm	Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months
Z-scores and percentiles	Changes in weight-for-age, weight-for-length, length-for-age, BMI-for-age, and head-circumference-for-age z-scores and percentiles calculated according to WHO standards	Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, 6 months, 10 months and 12 months.
Infant Complementary Food Intake	Descriptive data from complementary food questionnaire and 3-day food record	Infant age 6-12months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Incidents of adverse events from time of ICF signing at baseline, age ≥14 to ≤35 days, through the last study visit at age 12 months	From infant age ≥14 to ≤35 days to 12 months
Concomitant medications and treatments	All concomitant medications / treatments (including type and duration) used to treat illnesses and other conditions will be recorded continuously from time of ICF signing at baseline, age ≥14 to ≤35 days, through the last study visit at age 12 months	From infant age ≥14 to ≤35 days to 12 months

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Collaborators: Asian Hospital and Medical Center, Muntinlupa City, Philippines
• Investigators: Principal Investigator: Maria Rosario JK Capeding, MD, Asian Hospital and Medical Center, Philippines

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2024
• Primary Completion (Actual): January 30, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Breastfeeding; Immune system
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period; Lactation
• Other Study ID Numbers: 2313INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No