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Healthy InfantsNCT06073652

Starter Infant Formula With Synbiotics

A study testing Experimental 1st age starter infant formula in people with Healthy Infants, run by Société des Produits Nestlé (SPN) at 3 sites 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 randomized, double-blind, controlled intervention trial aims to evaluate the safety and efficacy of a starter infant formula supplemented with an HMO blend and a probiotic, and will provide evidence on the safety and efficacy of the innovative prebiotic/ probiotic blend to support age-appropriate infant growth, a… Read more about this study

Who is it for?
Ages 14 to 35 daysHealthy volunteers can take part
Conditions the study is for
Healthy Infants
What is being tested?
Experimental 1st age starter infant formula
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
3 sitesPhilippines
Study dates
5 Jul 2023to Sep 2027
Phase
Interventional
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

Who may be able to join

  • Evidence of personally signed and dated informed consent document indicating that at least one of the infant's parent(s)/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
  • Infants whose parent(s)/LAR(s) have reached the legal age of majority in the countries where the study is conducted.
  • 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) are able to be contacted directly by telephone throughout the study.
  • Infants must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Show all 11Show fewer
  • Healthy term infant (≥37 weeks of gestation).
  • At enrollment visit, post-natal age ≥14 to ≤35 days / 0.75 - 1 month (date of birth = day 0)
  • Birth weight ≥ 2500g and ≤ 4500g.
  • For formula-fed groups, infants must be exclusively consuming and tolerating a cow's milk infant formula at time of enrollment and their parent(s)/LAR(s) must have independently elected, before enrollment, not to breastfeed.
  • For the breastfed group, infants must have been exclusively consuming breastmilk since birth (small amounts of other feedings allowed during the first three days of life before breastfeeding is well-established), and their parent(s)/LAR(s) must have made the decision to continue exclusively breastfeeding until at least 4 months of age.

Who cannot join

  • Infants with conditions requiring infant feedings other than those specified in the protocol.
  • Infants who have 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.
  • Infants who are 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.
  • Currently participating or having participated in another interventional clinical trial since birth.

Trial locations and contacts

3 sites in 1 country.

Philippines3 sites

  • Asian Hospital and Medical Center

    Manila

  • University of Perpetual Help DALTA Medical Center

    Manila

  • University of the East Ramon Magsaysay Memorial Medical Center

    Manila

Other trials in Philippines

About this study

Official title: Safety and Efficacy of a Starter Infant Formula With Synbiotics: a Double-blind, Randomized, Controlled Trial

This randomized, double-blind, controlled intervention trial aims to evaluate the safety and efficacy of a starter infant formula supplemented with an HMO blend and a probiotic, and will provide evidence on the safety and efficacy of the innovative prebiotic/ probiotic blend to support age-appropriate infant growth, a healthy gut microbiome, gastrointestinal (GI) tolerance and GI health, and immune development.

Conditions
Healthy Infants
Being tested
Control 1st age starter infant formula, Experimental 1st age starter infant formula

What participants receive

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

  • Control 1st age starter infant formulaOther

    A standard bovine milk-based term infant formula.

  • Experimental 1st age starter infant formulaOther

    Same content as Control formula plus supplemented with a HMO blend and a probiotic

Study groups in NCT06073652
Study groupRoleWhat they receive
Control formula groupActive comparatorThe Control Formula group will receive 1st age infant formula exclusively for the first six months.
Receives: Other: Control 1st age starter infant formula
Experimental formula groupExperimentalThe Experimental Formula group will receive 1st age infant formula identical to Control formula, but supplemented with a HMO blend and a probiotic exclusively for the first six months.
Receives: Other: Experimental 1st age starter infant formula

What is being measured

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

  1. Safety of experimental formula demonstrated by growth

    Weight gain comparison between infants from experimental and control group

    Measured: Baseline Visit 1 to 4 months of age Visit 5

Secondary outcomes (17)

  1. Efficacy of experimental formula demonstrated by fecal sIgA concentration.

    Concentration of sIgA in fecal samples

    Measured: Baseline Visit 1 to 4 months of age Visit 5

  2. Fecal microbiome

    Fecal microbiota modulating effect

    Measured: Baseline Visit 1 to 6 month of age Visit 6

  3. Fecal metabolic profile

    Fecal pH, fecal organic acids measurement from fecal samples

    Measured: Baseline Visit 1 to 6 month of age Visit 6

  4. Fecal markers of immune health and gut barrier function

    Fecal markers of immune health and gut barrier, such as but not restricted to calprotectin and α-1-antitrypsin assessed by ELISA.

    Measured: Baseline Visit 1 to 6 month of age Visit 6

  5. Fecal cytokine profile

    Fecal cytokine profile (such as but not restricted to: IL-6, IL-8, IL-1b, IL-22, IFN-γ) using multiplex assays.

    Measured: Baseline Visit 1 to 6 month of age Visit 6

  6. Blood markers of systemic immunity

    Immunotyping and plasma immune proteomics and Vaccine specific antibodies measurement from blood samples

    Measured: Baseline Visit 1 to 4 months of age Visit 5

  7. 3-day GI Symptom and Behavior Diary

    GI tolerance, GI symptoms and GI-related behaviors

    Measured: Baseline Visit 1 to 6 month of age Visit 6

  8. Infant Gastrointestinal Symptom Questionnaire (IGSQ-13) Index questionnaire

    GI tolerance, GI symptoms and GI-related behaviors

    Measured: Baseline Visit 1 to 6 month of age Visit 6

  9. Weight (g)

    Anthropometric measurement. Weight and height will be combined to report BMI in kg/m^2

    Measured: Baseline Visit 1 to 6 month of age Visit 6

  10. Length (cm)

    Anthropometric measurement. Weight and height will be combined to report BMI in kg/m^2

    Measured: Baseline Visit 1 to 6 month of age Visit 6

  11. Head circumference (cm)

    Anthropometric measurement

    Measured: Baseline Visit 1 to 6 month of age Visit 6

  12. Respiration

    Vital signs

    Measured: Baseline Visit 1 to 6 month of age Visit 6

  13. Heart rate

    Vital signs

    Measured: Baseline Visit 1 to 6 month of age Visit 6

  14. Body temperature

    Vital signs

    Measured: Baseline Visit 1 to 6 month of age Visit 6

  15. Physical examination

    Infant illness and infection outcomes

    Measured: Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5

  16. Pediatric Immune System Index and Infant Illness Questionnaire

    Infant illness and infection outcomes

    Measured: Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5

  17. Antibiotic and antipyretic use

    Concomitant medication reporting

    Measured: Baseline Visit 1 to 6 month of age Phone visit 7

Timeline

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

  1. First posted10 Oct 2023
  2. Study start5 Jul 2023
  3. Primary completion14 Aug 2024
  4. Study completionSep 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
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06073652
Sponsor's protocol ID
21.14.INF
Status last verified
Jan 2026
First submitted
9 Nov 2022
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Experimental 1st age starter infant formula in people with Healthy Infants, run by Société des Produits Nestlé (SPN) at 3 sites 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 11 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Safety of experimental formula demonstrated by growth (time frame: Baseline Visit 1 to 4 months of age Visit 5). 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 NCT06073652.

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 15 Jan 2026.

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