An interventional study of Experimental Group and Control Group (CG) in Healthy Infants, sponsored by Société des Produits Nestlé (SPN). Recruiting at 2 sites in Philippines. Open to participants aged 19 Weeks to 21 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Not applicable, Interventional, and Other
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.
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.
Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Experimental Group
Other: Control Group (CG)
Dietary supplement in powder form
Placebo dietary supplement in powder form
Probiotic abundance
Fecal probiotic abundance
Time frame: At 5 months (V4) of intervention
Fecal metabolic biomarker
To assess changes in key fecal metabolic biomarkers such as fecal water-soluble vitamins, fecal organic acids, and other fecal metabolites.
Time frame: 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
Time frame: 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
Time frame: 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
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)
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1-day retrospective (V1) and 3-day prospective (V2, V3 and V4) of intervention
Fecal microbiota
Overall fecal microbiota composition, diversity, and function.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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).
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
Fecal markers of gut and immune health such as total secretory IgA (sIgA)
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
Fecal markers of gut and immune health such as fecal pH, fecal calprotectin, fecal α-1-antitrypsin, oral vaccine-specific fecal antibodies.
Time frame: 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.
Time frame: 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
Time frame: At 5 months (V4) of intervention
Plan to share: No
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