Starter Infant Formula With Synbiotics

Last updated: January 13, 2026
Sponsor: Société des Produits Nestlé (SPN)
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Experimental 1st age starter infant formula

Control 1st age starter infant formula

Experimental1st age starter infant formula

Clinical Study ID

NCT06073652
21.14.INF
  • Ages 14-35
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Evidence of personally signed and dated informed consent document indicating that atleast one of the infant's parent(s)/LAR(s), as per local regulation, have beeninformed of all pertinent aspects of the study.

  2. Infants whose parent(s)/LAR(s) have reached the legal age of majority in thecountries where the study is conducted.

  3. Able to temporarily store stool samples in a household freezer.

  4. Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits,and the requirements of the study protocol.

  5. Infants whose parent(s)/LAR(s) are able to be contacted directly by telephonethroughout the study.

  6. Infants must meet all of the following inclusion criteria to be eligible forenrollment into the study:

  7. Healthy term infant (≥37 weeks of gestation).

  8. At enrollment visit, post-natal age ≥14 to ≤35 days / 0.75 - 1 month (date ofbirth = day 0)

  9. Birth weight ≥ 2500g and ≤ 4500g.

  10. For formula-fed groups, infants must be exclusively consuming and tolerating acow's milk infant formula at time of enrollment and their parent(s)/LAR(s) musthave independently elected, before enrollment, not to breastfeed.

  11. For the breastfed group, infants must have been exclusively consumingbreastmilk since birth (small amounts of other feedings allowed during thefirst three days of life before breastfeeding is well-established), and theirparent(s)/LAR(s) must have made the decision to continue exclusivelybreastfeeding until at least 4 months of age.

Exclusion

Exclusion Criteria:

  1. Infants with conditions requiring infant feedings other than those specified in theprotocol.

  2. Infants who have a medical condition or history that could increase the riskassociated with study participation or interfere with the interpretation of studyresults, including:

  3. Evidence of major congenital malformations (e.g., cleft palate, extremitymalformation).

  4. Suspected or documented systemic or congenital infections (e.g., humanimmunodeficiency virus, cytomegalovirus, syphilis).

  5. Previous or ongoing severe medical or laboratory abnormality (acute or chronic)which, in the judgment of the investigator, would make the infant inappropriatefor entry into the study. Of note, children who are normally healthy but at thetime of enrolment suffering from acute illness in a minor condition which arecommon in childhood and do not require some of the exclusionary medicationmentioned below can be enrolled.

  6. Infants who are presently receiving or have received prior to enrolment any of thefollowing: medication(s) or supplement(s) which are known or suspected to affect thefollowing: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes);stool microbiota and characteristics (e.g., oral, or systemic antibiotics, glycerinsuppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose);growth (e.g., insulin or growth hormone); gastric acid secretion.

  7. Currently participating or having participated in another interventional clinicaltrial since birth.

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: Experimental 1st age starter infant formula
Phase:
Study Start date:
July 05, 2023
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • Asian Hospital and Medical Center

    Manila,
    Philippines

    Site Not Available

  • University of Perpetual Help DALTA Medical Center

    Manila,
    Philippines

    Site Not Available

  • University of the East Ramon Magsaysay Memorial Medical Center

    Manila,
    Philippines

    Site Not Available

  • Asian Hospital and Medical Center

    Manila 1701668,
    Philippines

    Site Not Available

  • University of Perpetual Help DALTA Medical Center

    Manila 1701668,
    Philippines

    Site Not Available

  • University of the East Ramon Magsaysay Memorial Medical Center

    Manila 1701668,
    Philippines

    Site Not Available

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