An interventional study of Probiotic dietary supplement and Placebo dietary supplement in Healthy Infants, sponsored by Société des Produits Nestlé (SPN). Recruiting at 2 sites in Philippines. Open to participants aged 14 Days to 28 Days, 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 aimed at investigating growth, tolerance, and functional biomarkers in healthy infants receiving dietary supplements from birth to 2.5 months of age
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.
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.
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 formula-fed infants (either exclusively or mixed-fed): parent(s) / LAR(s) must intend to maintain the infant's current mode of feeding, plus:
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.
Probiotic Supplement in powdered form
Dietary Supplement: Probiotic dietary supplement
Probiotic Supplement in powdered form
Dietary Supplement: Probiotic dietary supplement
Placebo Supplement in powdered form
Dietary Supplement: Placebo dietary supplement
Probiotic dietary supplement administered once per day
Also known as: dietary supplement
Placebo dietary supplement administered once per day
Weight gain velocity
Weight gain velocity (g/day)
Time frame: From baseline (V1) to 2.5 months (V3)
Growth Measure: Weight
Weight in grams and corresponding weight-for-age Z-scores according to World Health Organization (WHO) child growth standards
Time frame: 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
Time frame: 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
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)
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.
Time frame: 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.
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
Stool consistency recorded on a 5-point scale (1=watery, 5=hard) using a gastrointestinal symptom and behavior diary
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
Crying and sleeping time per day recorded using a gastrointestinal symptom and behavior diary
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
Volume of formula consumed per day (mL) and number of breastmilk feeds per day recorded using a gastrointestinal symptom and behavior diary
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)
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).
Time frame: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)
Fecal Microbiome: Abundance of Probiotic Strains
Fecal probiotic strain abundance
Time frame: At baseline (V1) and 2.5 months (V3)
Fecal Microbiome: Overall Compositional Profile
Overall fecal microbiota composition, including diversity and functional characteristics
Time frame: At baseline (V1) and 2.5 months (V3)
Fecal Metabolic Status: Fecal pH
Fecal pH
Time frame: At baseline (V1) and 2.5 months (V3)
Fecal Metabolic Status: Concentrations of Fecal Organic Acids
Concentration of fecal organic acids
Time frame: At baseline (V1) and 2.5 months (V3)
Fecal Metabolic Status: Fecal Metabolomic Profile
Relative and/or absolute concentrations of fecal metabolites
Time frame: At baseline (V1) and 2.5 months (V3)
Fecal Markers: Fecal Total Secretory Immunoglobulin A (sIgA)
Concentration of fecal sIgA
Time frame: At 2.5 months (V3) in exclusively formula-fed infants only
Fecal Markers: Fecal Alpha-1 Antitrypsin
Concentration of 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
Number of participants with abnormal physical examination findings (major body systems)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From baseline to 3.5 months
Plan to share: No
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