Healthy InfantsNCT07341477
Efficacy of a Dietary Supplement in Infants
A study testing Experimental Group in people with Healthy Infants, run by Société des Produits Nestlé (SPN) at 2 sites in Philippines.
Trial summary
This is a double-blind, randomized, placebo-controlled nutritional study of healthy term infants. The primary objective of the trial is to demonstrate a favorable change in fecal microbiome composition in infants receiving a dietary supplement compared to infants receiving a placebo supplement. Read more about this study
- Who is it for?
- Ages 19 to 21 weeksHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 2 sitesPhilippines
- Study dates
- 17 Aug 2026to May 2028
- 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 19 to 21 weeks
- 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 including infant blood collection
- 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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- Parent(s) / LAR(s) of formula-fed infants (either exclusively or mixed-fed) must have previously and independently decided to use formula and their 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)
- Infant age 5 months ± 1 week (date of birth = day 0) at time of clinic visit 1
- Infant birth weight is appropriate for gestational age (i.e., ≥ 2500 and ≤ 4500 grams)
Who cannot join
- Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol
- Infants receiving solid foods or liquids other than breastmilk or infant formula within 4 weeks prior to enrollment
- 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)
- 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 any infant formula containing probiotics prior to enrollment
- Infants who are currently receiving or who have previously 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, antibiotic usage within the past 4 weeks [not including topical or ophthalmic applications]), 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.
Philippines2 sites, 2 recruiting
- Recruiting
University of Perpetual Help DALTA Medical Center, Inc.
Las Piñas
Sheena Mae Ms, +63 0906 485 3459, shnamurao16@gmail.com
- Recruiting
Silang Specialist Medical Center
Silang
Billy Joel Mr, +63 0968 851 1623, bjabejero05@gmail.com
About this study
Official title: Microbiome and Health-related Effects of a Dietary Supplement in Infants: a Double-blind, Randomized, Placebo-controlled Nutritional Study.
This is a double-blind, randomized, placebo-controlled nutritional study of healthy term infants. The primary objective of the trial is to demonstrate a favorable change in fecal microbiome composition in infants receiving a dietary supplement compared to infants receiving a placebo supplement.
Read the detailed description
This is a double-blind, randomized, placebo-controlled nutritional study of healthy term infants, consisting of 2 randomized parallel arms: experimental group (EG) receiving a dietary supplement and a control group (CG) receiving a placebo supplement.
The population under investigation is healthy infants aged 5 months +/- 1 week at the time of clinic visit 1.
The planned sample size for this study is 172 infants (86 per study group). Each investigational product (EG and CG) will be provided in powder form and packaged in single dose stick packs. The powder will be dissolved in lukewarm formula or body temperature breastmilk and fed orally to the infants using a provided infant feeding beaker.
The primary objective of the trial is to demonstrate a favorable change in fecal microbiome composition in infants receiving a dietary supplement compared to infants receiving a placebo supplement from enrolment until 5 months of intervention.
In addition, fecal metabolic biomarkers, gastrointestinal (GI) related outcomes, blood markers of immune health, fecal markers of gut and immune health, bone quality, other anthropometric measurements, dietary pattern and infant illness and infection outcomes will be assessed/measured.
- Conditions
- Healthy Infants
- Being tested
- Experimental Group, Control Group (CG)
- Keywords
- Dietary Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupDietary supplement
Dietary supplement in powder form
Control Group (CG)Other
Placebo dietary supplement in powder form
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG) | Experimental | Not described Receives: Dietary Supplement: Experimental Group |
| Control Group (CG) | Placebo comparator | Not described Receives: Other: Control Group (CG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probiotic abundance
Fecal probiotic abundance
Measured: At 5 months (V4) of intervention
Secondary outcomes (17)
Fecal metabolic biomarker
To assess changes in key fecal metabolic biomarkers such as fecal water-soluble vitamins, fecal organic acids, and other fecal metabolites.
Measured: At baseline (V1), 3 months (V3), and 5 months (V4) of intervention.
Growth parameter: Weight
Weight in grams and corresponding weight-for-age Z-score according to WHO growth standards
Measured: At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention.
Growth parameter: Length
Length in cm and corresponding weight-for-age Z-score according to WHO growth standards
Measured: At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention.
Growth parameter: Head circumference
Head circumference in cm and corresponding head circumference-for-age Z-score according to WHO growth standards
Measured: At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention.
GI-related Behavior: Infant Gastrointestinal Symptom Questionnaire (IGSQ)
The questionnaire 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 to 65 with lower scores indicating lower GI symptom burden.
Measured: At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention.
GI-related behavior: Stool frequency
Stool frequency recorded via the GI Symptom and Behavior Diary
Measured: 1-day retrospective (V1) and 3-day prospective (V2, V3 and V4) of intervention
GI-related behavior: Stool consistency
Stool consistency recorded on a 5-point scale (1: watery, 5: hard) via the GI Symptom and Behavior Diary
Measured: 1-day retrospective (V1) and 3-day prospective (V2, V3 and V4) of intervention
GI-related behavior: Crying and sleeping
Crying and sleeping time via the GI Symptom and Behavior Diary
Measured: 1-day retrospective (V1) and 3-day prospective (V2, V3 and V4) of intervention
Fecal microbiota
Overall fecal microbiota composition, diversity, and function.
Measured: At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention.
Bone quality
Tibia bone transmission time and speed of sound. Tibia length assessed using a measuring tape.
Measured: At baseline (V1), 3 months (V3), and 5 months (V4) of intervention.
Dietary intake: Food record
Dietary intake using a 3-day food record completed at home
Measured: 3 consecutive days prior to study visit 3 (age 8 months) and visit 4 (age 10 months)
Dietary intake: Complementary foods
Exact timing of the introduction of different types of complementary foods assessed using the Complementary Food Questionnaire
Measured: Questionnaire to be completed prospectively starting at age 6 months
Dietary intake: Formula Composition
Key aspects of formula composition assessed using a questionnaire at each study visit for formula-fed infants (exclusively or mixed-fed).
Measured: At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention.
Fecal markers of gut and immune health: Formula-fed infants only
Fecal markers of gut and immune health such as total secretory IgA (sIgA)
Measured: At 1 month (V2), 3 months (V3), and 5 months (V4) of intervention in exclusively formula-fed infants only.
Fecal markers of gut and immune health: All infants
Fecal markers of gut and immune health such as fecal pH, fecal calprotectin, fecal α-1-antitrypsin, oral vaccine-specific fecal antibodies.
Measured: At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention in all infants.
Blood biomarkers
Blood biomarkers such as immunotyping, plasma immune proteomics, metabolic and anabolic biomarkers, plasma metabolomics, vaccine-specific antibodies, plasma short-chain fatty acids.
Measured: At baseline (V1), 3 months (V3), and 5 months (V4) of intervention.
Neurodevelopment: National Institute of Health (NIH) Baby Toolbox
To assess different aspects of infant neurodevelopment
Measured: At 5 months (V4) of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start17 Aug 2026
- Primary completion30 Sep 2027 (estimated)
- Study completionMay 2028 (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
- Double-blind, randomized, placebo-controlled nutritional study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Mitzi Trinidad-Aseron, Principal investigator, University of Perpetual Help Dalta Medical Center, PhilippinesDr. Maria Josefa Nantes, Principal investigator, Silang Specialists Medical Center, Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341477
- Sponsor's protocol ID
- 2406INF
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Microbiome and Health-related Effects of a Dietary Supplement in Infants: a Double-blind, Randomized, Placebo-controlled Nutritional Study.
- ClinicalTrials.gov ID
- NCT07341477
- Acronym / sponsor ID
- 2406INF
- Conditions
- Healthy Infants
- Keywords
- Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 14 Jan 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.
This is a double-blind, randomized, placebo-controlled nutritional study of healthy term infants. The primary objective of the trial is to demonstrate a favorable change in fecal microbiome composition in infants receiving a dietary supplement compared to infants receiving a placebo supplement.
Detailed description
This is a double-blind, randomized, placebo-controlled nutritional study of healthy term infants, consisting of 2 randomized parallel arms: experimental group (EG) receiving a dietary supplement and a control group (CG) receiving a placebo supplement.
The population under investigation is healthy infants aged 5 months +/- 1 week at the time of clinic visit 1.
The planned sample size for this study is 172 infants (86 per study group). Each investigational product (EG and CG) will be provided in powder form and packaged in single dose stick packs. The powder will be dissolved in lukewarm formula or body temperature breastmilk and fed orally to the infants using a provided infant feeding beaker.
The primary objective of the trial is to demonstrate a favorable change in fecal microbiome composition in infants receiving a dietary supplement compared to infants receiving a placebo supplement from enrolment until 5 months of intervention.
In addition, fecal metabolic biomarkers, gastrointestinal (GI) related outcomes, blood markers of immune health, fecal markers of gut and immune health, bone quality, other anthropometric measurements, dietary pattern and infant illness and infection outcomes will be assessed/measured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled nutritional study.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Dietary Supplement: Experimental Group |
| Control Group (CG) | Placebo comparator | Other: Control Group (CG) |
Who may qualify
- Ages
- 19 to 21 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 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 including infant blood collection
- 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 receiving solid foods or liquids other than breastmilk or infant formula within 4 weeks prior to enrollment
- 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 any infant formula containing probiotics prior to enrollment
- Infants who are currently receiving or who have previously 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, antibiotic usage within the past 4 weeks [not including topical or ophthalmic applications]), or gastric acid secretion.
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 |
|---|---|---|
| Experimental GroupDietary supplement in powder form | Dietary supplement | Experimental Group (EG) |
| Control Group (CG)Placebo dietary supplement in powder form | Other | Control Group (CG) |
Primary outcome
Probiotic abundance
Time frame: At 5 months (V4) of intervention
Fecal probiotic abundance
17 secondary outcomes
Fecal metabolic biomarker
Time frame: At baseline (V1), 3 months (V3), and 5 months (V4) of intervention.
Growth parameter: Weight
Time frame: At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention.
Growth parameter: Length
Time frame: At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention.
Growth parameter: Head circumference
Time frame: At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention.
GI-related Behavior: Infant Gastrointestinal Symptom Questionnaire (IGSQ)
Time frame: At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention.
GI-related behavior: Stool frequency
Time frame: 1-day retrospective (V1) and 3-day prospective (V2, V3 and V4) of intervention
GI-related behavior: Stool consistency
Time frame: 1-day retrospective (V1) and 3-day prospective (V2, V3 and V4) of intervention
GI-related behavior: Crying and sleeping
Time frame: 1-day retrospective (V1) and 3-day prospective (V2, V3 and V4) of intervention
Fecal microbiota
Time frame: At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention.
Bone quality
Time frame: At baseline (V1), 3 months (V3), and 5 months (V4) of intervention.
Dietary intake: Food record
Time frame: 3 consecutive days prior to study visit 3 (age 8 months) and visit 4 (age 10 months)
Dietary intake: Complementary foods
Time frame: Questionnaire to be completed prospectively starting at age 6 months
Dietary intake: Formula Composition
Time frame: At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention.
Fecal markers of gut and immune health: Formula-fed infants only
Time frame: At 1 month (V2), 3 months (V3), and 5 months (V4) of intervention in exclusively formula-fed infants only.
Fecal markers of gut and immune health: All infants
Time frame: At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention in all infants.
Blood biomarkers
Time frame: At baseline (V1), 3 months (V3), and 5 months (V4) of intervention.
Neurodevelopment: National Institute of Health (NIH) Baby Toolbox
Time frame: At 5 months (V4) of intervention
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
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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.
Dr. Mitzi Trinidad-Aseron principal investigator
University of Perpetual Help Dalta Medical Center, Philippines
Dr. Maria Josefa Nantes principal investigator
Silang Specialists 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 Experimental Group 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 11 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 Qiaoji Li (+861087419794, Qiaoji.Li@rd.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probiotic abundance (time frame: At 5 months (V4) of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.