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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
327
Probiotic dietary supplement administered once per day
Placebo dietary supplement administered once per day
Health Index Multispecialty and Lying-In Clinic
Cavite City, Manila, Philippines
RECRUITINGUniversity of the East Ramon Magsaysay Memorial Medical Center, Inc.
Quezon City, Manila, Philippines
RECRUITINGWeight 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)
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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