Healthy InfantsNCT07630584

Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements

A study testing Probiotic dietary supplement in people with Healthy Infants, run by Société des Produits Nestlé (SPN) at 2 sites in Philippines.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a double-blind, randomized, placebo-controlled nutritional study aimed at investigating growth, tolerance, and functional biomarkers in healthy infants receiving dietary supplements from birth to 2.5 months of age Read more about this study

Who is it for?: Ages 14 to 28 daysHealthy volunteers can take part
Conditions the study is for: Healthy Infants
What is being tested?: Probiotic dietary supplement
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 327 participants
Where: 2 sitesPhilippines
Study dates: 11 Aug 2026to 31 Dec 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 28 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Written informed consent has been obtained from at least one parent (or legally acceptable representative [LAR])
Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity
Parent(s) / LAR(s) must understand the informed consent form and other study documents
Parent(s) / LAR(s) are willing and able to comply with scheduled visits and the requirements of the study protocol
Parent(s) / LAR(s) can be contacted directly by telephone throughout the study
Parent(s) / LAR(s) must be able to temporarily store stool samples in a household freezer

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Infants may be exclusively breastfed, exclusively formula-fed, or mixed fed with both breast milk and infant formula in any proportion. Parent(s) / LAR(s) must intend to maintain the infant's current mode of feeding until the end of the study period:
For exclusively breastfed infants: parents must intend to continue exclusive breastfeeding. As defined by the World Health Organization, exclusive breastfeeding means that the infant receives only breast milk. No other liquids or solids are given (not even water) with the exception of oral rehydration solution, or drops/syrups of vitamins, minerals, or medicines.
For formula-fed infants (either exclusively or mixed-fed): parent(s) / LAR(s) must intend to maintain the infant's current mode of feeding, plus:
Parents / LAR(s) must have previously and independently decided to use formula
Infant must be consuming and tolerating a standard cow's milk infant formula not containing probiotics at the time of enrollment
Infant must be healthy based on medical history and physical examination
Infant full-term gestational birth (born 37 weeks, 0 days through 41 weeks, 6 days of gestation)
Infant singleton birth
Infant postnatal age ≥ 14 and ≤ 28 days (date of birth = day 0)
Infant birth weight is appropriate for gestational age (≥ 2500 and ≤ 4500 grams)

Who cannot join

Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol
Infants who have a medical condition or medical 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 antibiotic usage by the infant, except when given for prophylactic reasons (e.g., erythromycin ophthalmic ointment)
Immunocompromised infants and those who have a central venous catheter

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History of admission to the Neonatal Intensive Care Unit, except for admission for jaundice phototherapy
Known or suspected allergy to milk (including lactose) or soy
Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgement of the investigator, would make the infant inappropriate for entry into the study
Infants who are currently receiving or who have received any probiotic supplements or infant formula containing probiotics prior to enrollment
Infants who are currently receiving or who have received any of the following medication(s) or supplement(s) which are known or suspected to affect fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes), stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose), growth (e.g. insulin or growth hormone), microbiome-related endpoints (e.g., prebiotic supplements), or gastric acid secretion
Infants whose parent(s) / LAR(s) have not reached the legal age of majority (18 years old)
Infants who are currently or who previously participated in another interventional clinical study
Parent(s) / LAR(s) with family or hierarchical relationships with the research team members

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Joyce Li contact

+8615810125435

joyce.li@rd.nestle.com

Philippines2 sites, 2 recruiting

Health Index Multispecialty and Lying-In Clinic
Cavite City, Manila
Karla Keith Abana Ms, +63 917 6371753, karlakeith.abana@iconplc.com
Edison Alberto
Recruiting
University of the East Ramon Magsaysay Memorial Medical Center, Inc.
Quezon City, Manila
Karla Keith Abana Ms, +63 917 6371753, karlakeith.abana@iconplc.com
Vinna Marie Quinones
Recruiting

Other trials in Philippines

About this study

Official title: Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements: A Double-blind, Randomized Placebo-controlled Nutritional Study

Read the detailed description

This is a double-blind, randomized, placebo-controlled nutritional study in healthy term infants of all feeding types. Approximately 327 infants aged 14 to 28 days at enrollment will be recruited and followed up until 2.5 months of age.

The 8-weeks interventional period will be followed by a 4-week follow-up period. The total duration of the study is approximately 3 months.

The primary objective of this clinical study is to demonstrate non-inferior weight gain from enrollment until 8 weeks of intervention in healthy infants randomized into 3 experimental groups of single probiotic, multi-probiotic, and control group.

The secondary objectives will include growth patterns, gastrointestinal tolerance, gastrointestinal related outcomes, fecal microbiome composition, fecal metabolic status, and biomarkers of gut and immune health as well as safety outcomes from enrollment until 4 weeks after last consumption of the investigational product.

Conditions: Healthy Infants
Being tested: Probiotic dietary supplement, Placebo dietary supplement
Keywords: Dietary Supplement

What participants receive

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

Probiotic dietary supplementDietary supplement
Also called dietary supplement
Probiotic dietary supplement administered once per day
Placebo dietary supplementDietary supplement
Placebo dietary supplement administered once per day

Study groups in NCT07630584
Study group	Role	What they receive
EG1 Supplement	Experimental	Probiotic Supplement in powdered form Receives: Dietary Supplement: Probiotic dietary supplement
EG2 Supplement	Experimental	Probiotic Supplement in powdered form Receives: Dietary Supplement: Probiotic dietary supplement
CG supplement	Placebo comparator	Placebo Supplement in powdered form Receives: Dietary Supplement: Placebo dietary supplement

What is being measured

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

Weight gain velocity
Weight gain velocity (g/day)
Measured: From baseline (V1) to 2.5 months (V3)

Secondary outcomes (20)

Growth Measure: Weight
Weight in grams and corresponding weight-for-age Z-scores according to World Health Organization (WHO) child growth standards
Measured: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
Growth Measure: Length
Length in centimeters and corresponding length-for-age Z-scores according to WHO child growth standards
Measured: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
Growth Measure: Head circumference
Head circumference in centimeters and corresponding head circumference-for-age Z-scores according to WHO child growth standards
Measured: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Infant Gastrointestinal Symptom Questionnaire (IGSQ)
The IGSQ is composed of 13 questions, categorized into 5 symptom domains of stooling, vomiting/spitting-up, crying, fussiness, and flatulence. The total score can range from 13-65 with lower scores indicating lower gastrointestinal symptom burden.
Measured: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Stool Frequency
Number of stools per day recorded using a gastrointestinal symptom and behavior diary.
Measured: At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary)
Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Stool Consistency
Stool consistency recorded on a 5-point scale (1=watery, 5=hard) using a gastrointestinal symptom and behavior diary
Measured: At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary)
Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Crying and Sleeping
Crying and sleeping time per day recorded using a gastrointestinal symptom and behavior diary
Measured: At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary)
Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: volume of formula consumed per day/number of breastmilk feeds per day
Volume of formula consumed per day (mL) and number of breastmilk feeds per day recorded using a gastrointestinal symptom and behavior diary
Measured: At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary)
Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Infant Colic Questionnaire (ColiQ)
The ColiQ is a 16-item questionnaire that includes 10 questions describing infant colic symptoms and 6 questions describing parental impact. The total score can range from 0 to 100, with higher scores indicating an overall better state (fewer / less severe symptoms and lower parental impact).
Measured: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
Fecal Microbiome: Abundance of Probiotic Strains
Fecal probiotic strain abundance
Measured: At baseline (V1) and 2.5 months (V3)
Fecal Microbiome: Overall Compositional Profile
Overall fecal microbiota composition, including diversity and functional characteristics
Measured: At baseline (V1) and 2.5 months (V3)
Fecal Metabolic Status: Fecal pH
Fecal pH
Measured: At baseline (V1) and 2.5 months (V3)
Fecal Metabolic Status: Concentrations of Fecal Organic Acids
Concentration of fecal organic acids
Measured: At baseline (V1) and 2.5 months (V3)
Fecal Metabolic Status: Fecal Metabolomic Profile
Relative and/or absolute concentrations of fecal metabolites
Measured: At baseline (V1) and 2.5 months (V3)
Fecal Markers: Fecal Total Secretory Immunoglobulin A (sIgA)
Concentration of fecal sIgA
Measured: At 2.5 months (V3) in exclusively formula-fed infants only
Fecal Markers: Fecal Alpha-1 Antitrypsin
Concentration of fecal alpha-1 antitrypsin
Measured: At baseline (V1) and 2.5 months (V3) for all infants regardless of feeding regimen
Safety Outcome: Physical Examination
Number of participants with abnormal physical examination findings (major body systems)
Measured: At baseline (V1), 1.5 months (V2) and 2.5 months (V3)
Safety Outcome: Vital signs
Number of participants with abnormal vital signs (temperature, pulse, respiration)
Measured: At baseline (V1), 1.5 months (V2) and 2.5 months (V3)
Safety Outcome: Adverse Events
Reported adverse events including type, incidence, severity, seriousness, and relation to the intervention
Measured: From baseline to 3.5 months
Safety Outcome: Concomitant Medications
Reported concomitant medications used to treat illnesses and other conditions, including name, dose, and duration
Measured: From baseline to 3.5 months

Timeline

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

11 Aug 202631 Dec 2027

First posted5 Jun 2026
Study start11 Aug 2026
Primary completion31 Jul 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy InfantsStudies of the same condition, open and under way.
More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Model description: a double-blind, randomized, placebo-controlled nutritional study
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 327 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07630584
Sponsor's protocol ID: 2403INF
Status last verified: Sep 2026
First submitted: 10 Feb 2026
Last updated: 14 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Joyce Li

+8615810125435

joyce.li@rd.nestle.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruitingPhase 2
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A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants

All Healthy Infants trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements: A Double-blind, Randomized Placebo-controlled Nutritional Study
ClinicalTrials.gov ID: NCT07630584
Acronym / sponsor ID: 2403INF
Conditions: Healthy Infants
Keywords: Dietary Supplement
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 327 participants (estimated)
Lead sponsor: Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
Collaborators: University of the East Ramon Magsaysay Memorial Medical Center, Inc, Philippines, Asian Hospital and Medical Center, Muntinlupa, Philippines
Study start: 11 Aug 2026 (actual)
Primary completion: 31 Jul 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 5 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The 8-weeks interventional period will be followed by a 4-week follow-up period. The total duration of the study is approximately 3 months.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: a double-blind, randomized, placebo-controlled nutritional study

Arm	Type	Receives
EG1 Supplement	Experimental	Dietary Supplement: Probiotic dietary supplementProbiotic Supplement in powdered form
EG2 Supplement	Experimental	Dietary Supplement: Probiotic dietary supplementProbiotic Supplement in powdered form
CG supplement	Placebo comparator	Dietary Supplement: Placebo dietary supplementPlacebo Supplement in powdered form

Who may qualify

Ages: 14 to 28 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (16 listed)

Written informed consent has been obtained from at least one parent (or legally acceptable representative [LAR])
Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity
Parent(s) / LAR(s) must understand the informed consent form and other study documents
Parent(s) / LAR(s) are willing and able to comply with scheduled visits and the requirements of the study protocol
Parent(s) / LAR(s) can be contacted directly by telephone throughout the study

Key exclusion criteria (14 listed)

Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol
Infants who have a medical condition or medical history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
Infants who are currently receiving or who have received any probiotic supplements or infant formula containing probiotics prior to enrollment
Infants who are currently receiving or who have received any of the following medication(s) or supplement(s) which are known or suspected to affect fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes), stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose), growth (e.g. insulin or growth hormone), microbiome-related endpoints (e.g., prebiotic supplements), or gastric acid secretion
Infants whose parent(s) / LAR(s) have not reached the legal age of majority (18 years old)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Probiotic dietary supplementAlso: dietary supplementProbiotic dietary supplement administered once per day	Dietary supplement	EG1 Supplement, EG2 Supplement
Placebo dietary supplementPlacebo dietary supplement administered once per day	Dietary supplement	CG supplement

Primary outcome

Weight gain velocity
Time frame: From baseline (V1) to 2.5 months (V3)
Weight gain velocity (g/day)

20 secondary outcomes

Growth Measure: Weight
Time frame: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
Growth Measure: Length
Time frame: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
Growth Measure: Head circumference
Time frame: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Infant Gastrointestinal Symptom Questionnaire (IGSQ)
Time frame: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Stool Frequency
Time frame: At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary)
Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Stool Consistency
Time frame: At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary)
Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Crying and Sleeping
Time frame: At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary)
Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: volume of formula consumed per day/number of breastmilk feeds per day
Time frame: At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary)
Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Infant Colic Questionnaire (ColiQ)
Time frame: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
Fecal Microbiome: Abundance of Probiotic Strains
Time frame: At baseline (V1) and 2.5 months (V3)
Fecal Microbiome: Overall Compositional Profile
Time frame: At baseline (V1) and 2.5 months (V3)
Fecal Metabolic Status: Fecal pH
Time frame: At baseline (V1) and 2.5 months (V3)
Fecal Metabolic Status: Concentrations of Fecal Organic Acids
Time frame: At baseline (V1) and 2.5 months (V3)
Fecal Metabolic Status: Fecal Metabolomic Profile
Time frame: At baseline (V1) and 2.5 months (V3)
Fecal Markers: Fecal Total Secretory Immunoglobulin A (sIgA)
Time frame: At 2.5 months (V3) in exclusively formula-fed infants only
Fecal Markers: Fecal Alpha-1 Antitrypsin
Time frame: At baseline (V1) and 2.5 months (V3) for all infants regardless of feeding regimen
Safety Outcome: Physical Examination
Time frame: At baseline (V1), 1.5 months (V2) and 2.5 months (V3)
Safety Outcome: Vital signs
Time frame: At baseline (V1), 1.5 months (V2) and 2.5 months (V3)
Safety Outcome: Adverse Events
Time frame: From baseline to 3.5 months
Safety Outcome: Concomitant Medications
Time frame: From baseline to 3.5 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Healthy Infants

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
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RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
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Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
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Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Joyce Li contact

+8615810125435

joyce.li@rd.nestle.com

Dr Edison Alberto principal investigator

Dr Vinna Marie Quinones principal investigator

University of East Ramon Magsaysay Memorial Medical center, Philippines

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic dietary supplement in people with Healthy Infants, run by Société des Produits Nestlé (SPN) at 2 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 16 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 14 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 2 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. Some participants in this study may receive a placebo. 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?

Contact Joyce Li (+8615810125435, joyce.li@rd.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight gain velocity (time frame: From baseline (V1) to 2.5 months (V3)). 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 NCT07630584.

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 14 Sep 2026.