Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements

NCT07630584 | Not Yet Recruiting DMC

• 1 other identifier: 2403INF
• Study Type: interventional
• Target: 327
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy Infants

Keywords

Dietary Supplement

Outcome Measures

Primary Outcomes (1)

• Weight gain velocity

  Weight gain velocity (g/day)

  From baseline (V1) to 2.5 months (V3)

Secondary Outcomes (20)

• Growth Measure: Weight

  At baseline (V1), 1.5 months (V2), and 2.5 months (V3)

• Growth Measure: Length

  At baseline (V1), 1.5 months (V2), and 2.5 months (V3)

• Growth Measure: Head circumference

  At baseline (V1), 1.5 months (V2), and 2.5 months (V3)

• Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Infant Gastrointestinal Symptom Questionnaire (IGSQ)

  At baseline (V1), 1.5 months (V2), and 2.5 months (V3)

• 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)

Study Arms (3)

EG1 Supplement

EXPERIMENTAL

Probiotic Supplement in powdered form

Dietary Supplement: Probiotic dietary supplement

EG2 Supplement

EXPERIMENTAL

Probiotic Supplement in powdered form

Dietary Supplement: Probiotic dietary supplement

CG supplement

PLACEBO COMPARATOR

Placebo Supplement in powdered form

Dietary Supplement: Placebo dietary supplement

Interventions

Probiotic dietary supplement DIETARY_SUPPLEMENT

Probiotic dietary supplement administered once per day

Also known as: dietary supplement

EG1 Supplement; EG2 Supplement

Placebo dietary supplement DIETARY_SUPPLEMENT

Placebo dietary supplement administered once per day

CG supplement

Eligibility Criteria

• Age: 14 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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
• 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 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.
• 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
• 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 of gestation)
• Infant singleton birth
• Infant postnatal age ≥ 14 and ≤ 28 days (date of birth = day 0)

You may not qualify if:

• Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol
• 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)
• Previous or ongoing antibiotic usage by the infant, except when given for prophylactic reasons (e.g., erythromycin ophthalmic ointment)
• Immunocompromised infants and those who have a central venous catheter
• 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 infant formula containing probiotics prior to enrollment
• 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
• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Asian Hospital and Medical Center, Muntinlupa, Philippines: collaborator
• University of the East Ramon Magsaysay Memorial Medical Center, Inc, Philippines: collaborator

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dr Edison Alberto

  PRINCIPAL INVESTIGATOR

• Dr Vinna Marie Quinones

  University of East Ramon Magsaysay Memorial Medical center, Philippines

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joelyn Jee Keh Chee

CONTACT

+6568905711; joelynjeekeh.chee@rd.nestle.com

Anthony De Cozar

CONTACT

+41217858573; Anthony.deCozar@rd.nestle.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Unique (individual) coding of the study products.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a double-blind, randomized, placebo-controlled nutritional study

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share