Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants

Active, not recruiting

• Conditions: Healthy

• Registration Number: NCT06708559
• Lead Sponsor: Société des Produits Nestlé (SPN)

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 6 months of age. An optional follow-up period of approximately 2.5 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 6 month of age at 4 on-site visits: V1 (baseline), V3 (2 months), V5 (4 months), and V6 (6 month).

The 6-month observational period will be followed by a 2.5-year 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 fecal microbiome, interactions between immune development and microbiome maturation, infant fecal metabolic profile and pH, infant gastrointestinal (GI) tolerance, infant anthropometric measurements, as well as infant illness and infection.

Study Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-27
• Study Start: 2024-11-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Markers of systemic immunity	Infant age ≥14 to ≤35 days, 2 months, 4 months, and 6 months	Descriptive statistics of plasma immune proteomics using mass cytometry or immunoassays, and vaccine-specific antibodies assessed by ELISA

Secondary Outcome Measures

Name	Time	Method
Fecal markers of immune health and gut barrier	Infant age ≥14 to ≤35 days, 2 months, 4 months, and 6 months	* 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 fecal microbiome	Infant age ≥14 to ≤35 days, 2 months, 4 months, and 6 months	Microbiota composition, diversity, community types, and abundance of bacteria taxa
Fecal metabolic profile and pH	Infant age ≥14 to ≤35 days, 2 months, 4 months, and 6 months	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
GI Tolerance	Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, and 6 months	* 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)
Weight	Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, and 6 months	Measurement of weight in grams
Length	Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, and 6 months	Measurement of length in cm
Head circumference	Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, and 6 months	Measurement of head circumference in cm
Z-scores and percentiles	Infant age ≥14 to ≤35 days, 1.5 months, 2 months, 3 months, 4 months, and 6 months	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 illness and infection	Infant age 6 months	Descriptive data and overall score derived from the Pediatric Immune System Index Questionnaire completed by parents
Long-term infant illness (during the optional follow-up)	Infant age 12 months, 18 months, 24 months, 30 months, and 36 months	Descriptive data from the Infant Illness Questionnaire completed by parents

Trial Locations

Locations (1)

Asian Hospital and Medical Center; 🇵🇭 Manila, Philippines