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HealthyNCT06708559

Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants

An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 35 daysHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Breast-fed infants
How many people
60 participants
Where
1 sitePhilippines
Study dates
29 Nov 2024to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 35 days
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

  • 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.
Show all 12Show fewer
  • Infants whose parent(s)/LAR(s) can be contacted directly by telephone throughout the study.
  • Infants must meet all the following inclusion criteria to be eligible for enrollment into 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.

Who cannot join

  • 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).
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Philippines1 site

  • Asian Hospital and Medical Center

    Manila, Manila, 1780

Other trials in Philippines

About this study

Official title: 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.

Read the 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
Being tested
Breast-fed infants
Keywords
Immune system, Breastfeeding
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breast-fed infantsOther

    Immune system characterization via blood and stool samples collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Markers of systemic immunity

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

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

Secondary outcomes (12)

  1. 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

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

  2. Infant fecal microbiome

    Microbiota composition, diversity, community types, and abundance of bacteria taxa

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

  3. 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

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

  4. Plasma Metabolomics

    Untargeted Plasma metabolomics Analyses

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

  5. 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)

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

  6. Weight

    Measurement of weight in grams

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

  7. Length

    Measurement of length in cm

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

  8. Head circumference

    Measurement of head circumference in cm

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

  9. 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

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

  10. Infant illness and infection

    Descriptive data and overall score derived from the Pediatric Immune System Index Questionnaire completed by parents

    Measured: Infant age 6 months

  11. Infant Complementary Food Intake

    Descriptive data from complementary food questionnaire and 3-day food record

    Measured: Infant age 6-12months

  12. Long-term infant illness (during the optional follow-up)

    Descriptive data from the Infant Illness Questionnaire completed by parents

    Measured: Infant age 12 months, 18 months, 24 months, 30 months, and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2024
  2. Study start29 Nov 2024
  3. Primary completion30 Jan 2026
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06708559
Sponsor's protocol ID
2313INF
Status last verified
Sep 2026
First submitted
5 Nov 2024
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Markers of systemic immunity (time frame: Infant age ≥14 to ≤35 days, 2 months, 4 months, 6 months and 12months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06708559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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Clinical Trial NCT06708559 | AzTrials