Starter Infant Formula With Synbiotics

NCT06073652 | Active Not Recruiting

• 1 other identifier: 21.14.INF
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

Brief Summary

This randomized, double-blind, controlled intervention trial aims to evaluate the safety and efficacy of a starter infant formula supplemented with an HMO blend and a probiotic, and will provide evidence on the safety and efficacy of the innovative prebiotic/ probiotic blend to support age-appropriate infant growth, a healthy gut microbiome, gastrointestinal (GI) tolerance and GI health, and immune development.

Conditions

Healthy Infants

Outcome Measures

Primary Outcomes (1)

• Safety of experimental formula demonstrated by growth

  Weight gain comparison between infants from experimental and control group

  Baseline Visit 1 to 4 months of age Visit 5

Secondary Outcomes (17)

• Efficacy of experimental formula demonstrated by fecal sIgA concentration.

  Baseline Visit 1 to 4 months of age Visit 5

• Fecal microbiome

  Baseline Visit 1 to 6 month of age Visit 6

• Fecal metabolic profile

  Baseline Visit 1 to 6 month of age Visit 6

• Fecal markers of immune health and gut barrier function

  Baseline Visit 1 to 6 month of age Visit 6

• Fecal cytokine profile

  Baseline Visit 1 to 6 month of age Visit 6

Study Arms (2)

Control formula group

ACTIVE COMPARATOR

The Control Formula group will receive 1st age infant formula exclusively for the first six months.

Other: Control 1st age starter infant formula

Experimental formula group

EXPERIMENTAL

The Experimental Formula group will receive 1st age infant formula identical to Control formula, but supplemented with a HMO blend and a probiotic exclusively for the first six months.

Other: Experimental 1st age starter infant formula

Interventions

Control 1st age starter infant formula OTHER

A standard bovine milk-based term infant formula.

Control formula group

Experimental 1st age starter infant formula OTHER

Same content as Control formula plus supplemented with a HMO blend and a probiotic

Experimental formula group

Eligibility Criteria

• Age: 14 Days - 35 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Evidence of personally signed and dated informed consent document indicating that at least one of the infant's parent(s)/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
• Infants whose parent(s)/LAR(s) have reached the legal age of majority in the countries where the study is conducted.
• Able to temporarily store stool samples in a household freezer.
• Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits, and the requirements of the study protocol.
• Infants whose parent(s)/LAR(s) are able to be contacted directly by telephone throughout the study.
• Healthy term infant (≥37 weeks of gestation).
• At enrollment visit, post-natal age ≥14 to ≤35 days / 0.75 - 1 month (date of birth = day 0)
• Birth weight ≥ 2500g and ≤ 4500g.
• For formula-fed groups, infants must be exclusively consuming and tolerating a cow's milk infant formula at time of enrollment and their parent(s)/LAR(s) must have independently elected, before enrollment, not to breastfeed.
• For the breastfed group, infants must have been exclusively consuming breastmilk since birth (small amounts of other feedings allowed during the first three days of life before breastfeeding is well-established), and their parent(s)/LAR(s) must have made the decision to continue exclusively breastfeeding until at least 4 months of age.

You may not qualify if:

• Infants with conditions requiring infant feedings other than those specified in the protocol.
• Infants who have a medical condition or 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).
• Infants who are presently receiving or have received prior to enrolment any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool microbiota and characteristics (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g., insulin or growth hormone); gastric acid secretion.
• Currently participating or having participated in another interventional clinical trial since birth.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Iqvia Pty Ltd: collaborator

Study Sites (3)

Asian Hospital and Medical Center

Manila, Philippines

Location

University of Perpetual Help DALTA Medical Center

Manila, Philippines

Location

University of the East Ramon Magsaysay Memorial Medical Center

Manila, Philippines

Location

Study Officials

• Maria Rosario Capeding, Dr

  Asian Hospital Medical Center

  PRINCIPAL INVESTIGATOR

• Mitzi Trinidad Aseron, Dr

  University of Perpetual Help Dalta Medical Center

  PRINCIPAL INVESTIGATOR

• Vinna Marie Quinones, Dr

  University of the East Ramon Magsaysay Memorial Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: There are two masked, randomized formula-fed intervention groups, Control Formula (CF) and experimental Formula (EF)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: October 10, 2023
• Study Start: July 5, 2023
• Primary Completion: August 14, 2024
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

PH (3)