Healthy Infants
Conditions
Keywords
Dietary Supplement
Brief 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
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.
Interventions
DIETARY_SUPPLEMENTProbiotic dietary supplement
Probiotic dietary supplement administered once per day
DIETARY_SUPPLEMENTPlacebo dietary supplement
Placebo dietary supplement administered once per day
Sponsors
Société des Produits Nestlé (SPN)
University of the East Ramon Magsaysay Memorial Medical Center, Inc, Philippines
Asian Hospital and Medical Center, Muntinlupa, Philippines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Unique (individual) coding of the study products.
Intervention model description
a double-blind, randomized, placebo-controlled nutritional study
Eligibility
Sex/Gender
ALL
Age
14 Days to 28 Days
Healthy volunteers
Yes
Inclusion criteria
1. Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]) 2. Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity 3. Parent(s) / LAR(s) must understand the informed consent form and other study documents 4. Parent(s) / LAR(s) are willing and able to comply with scheduled visits and the requirements of the study protocol 5. Parent(s) / LAR(s) can be contacted directly by telephone throughout the study 6. Parent(s) / LAR(s) must be able to temporarily store stool samples in a household freezer 7. 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: 1. 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. 2. 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 8. Infant must be healthy based on medical history and physical examination 9. Infant full-term gestational birth (born 37 weeks, 0 days through 41 weeks, 6 days of gestation) 10. Infant singleton birth 11. Infant postnatal age ≥ 14 and ≤ 28 days (date of birth = day 0) 12. Infant birth weight is appropriate for gestational age (≥ 2500 and ≤ 4500 grams)
Exclusion criteria
1. Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol 2. 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: 1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation) 2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis) 3. Previous or ongoing antibiotic usage by the infant, except when given for prophylactic reasons (e.g., erythromycin ophthalmic ointment) 4. Immunocompromised infants and those who have a central venous catheter 5. History of admission to the Neonatal Intensive Care Unit, except for admission for jaundice phototherapy 6. Known or suspected allergy to milk (including lactose) or soy 7. 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 3. Infants who are currently receiving or who have received any probiotic supplements or infant formula containing probiotics prior to enrollment 4. 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 5. Infants whose parent(s) / LAR(s) have not reached the legal age of majority (18 years old) 6. Infants who are currently or who previously participated in another interventional clinical study 7. Parent(s) / LAR(s) with family or hierarchical relationships with the research team members
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain velocity | From baseline (V1) to 2.5 months (V3) | Weight gain velocity (g/day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth Measure: Weight | At baseline (V1), 1.5 months (V2), and 2.5 months (V3) | Weight in grams and corresponding weight-for-age Z-scores according to World Health Organization (WHO) child growth standards |
| Growth Measure: Length | At baseline (V1), 1.5 months (V2), and 2.5 months (V3) | Length in centimeters and corresponding length-for-age Z-scores according to WHO child growth standards |
| Growth Measure: Head circumference | At baseline (V1), 1.5 months (V2), and 2.5 months (V3) | Head circumference in centimeters and corresponding head circumference-for-age Z-scores according to WHO child growth standards |
| Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Infant Gastrointestinal Symptom Questionnaire (IGSQ) | At baseline (V1), 1.5 months (V2), and 2.5 months (V3) | 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. |
| Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Stool Frequency | At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary) | Number of stools per day recorded using a gastrointestinal symptom and behavior diary. |
| Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Stool Consistency | At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary) | Stool consistency recorded on a 5-point scale (1=watery, 5=hard) using a gastrointestinal symptom and behavior diary |
| Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Crying and Sleeping | At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary) | Crying and sleeping time per day recorded using a gastrointestinal symptom and behavior diary |
| Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: volume of formula consumed per day/number of breastmilk feeds per day | At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary) | Volume of formula consumed per day (mL) and number of breastmilk feeds per day recorded using a gastrointestinal symptom and behavior diary |
| Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Infant Colic Questionnaire (ColiQ) | At baseline (V1), 1.5 months (V2), and 2.5 months (V3) | 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). |
| Fecal Microbiome: Abundance of Probiotic Strains | At baseline (V1) and 2.5 months (V3) | Fecal probiotic strain abundance |
| Fecal Microbiome: Overall Compositional Profile | At baseline (V1) and 2.5 months (V3) | Overall fecal microbiota composition, including diversity and functional characteristics |
| Fecal Metabolic Status: Fecal pH | At baseline (V1) and 2.5 months (V3) | Fecal pH |
| Fecal Metabolic Status: Concentrations of Fecal Organic Acids | At baseline (V1) and 2.5 months (V3) | Concentration of fecal organic acids |
| Fecal Metabolic Status: Fecal Metabolomic Profile | At baseline (V1) and 2.5 months (V3) | Relative and/or absolute concentrations of fecal metabolites |
| Fecal Markers: Fecal Total Secretory Immunoglobulin A (sIgA) | At 2.5 months (V3) in exclusively formula-fed infants only | Concentration of fecal sIgA |
| Fecal Markers: Fecal Alpha-1 Antitrypsin | At baseline (V1) and 2.5 months (V3) for all infants regardless of feeding regimen | Concentration of fecal alpha-1 antitrypsin |
| Safety Outcome: Physical Examination | At baseline (V1), 1.5 months (V2) and 2.5 months (V3) | Number of participants with abnormal physical examination findings (major body systems) |
| Safety Outcome: Vital signs | At baseline (V1), 1.5 months (V2) and 2.5 months (V3) | Number of participants with abnormal vital signs (temperature, pulse, respiration) |
| Safety Outcome: Adverse Events | From baseline to 3.5 months | Reported adverse events including type, incidence, severity, seriousness, and relation to the intervention |
| Safety Outcome: Concomitant Medications | From baseline to 3.5 months | Reported concomitant medications used to treat illnesses and other conditions, including name, dose, and duration |
Countries
Philippines
Contacts
CONTACTJoyce Li
PRINCIPAL_INVESTIGATORDr Edison Alberto
PRINCIPAL_INVESTIGATORDr Vinna Marie Quinones
University of East Ramon Magsaysay Memorial Medical center, Philippines
Outcome results
None listed