Safety and Efficacy Study

• Register: ClinicalTrials.gov
• Last refreshed on: 18 October 2021
• Main ID: NCT02670863
• Date of registration: 20/01/2016
• Prospective Registration: Yes
• Primary sponsor: Nestlé
• Public title: Safety and Efficacy Study
• Scientific title: Safety and Efficacy of a New Term Infant Formula Supplemented With A Prebiotic: a Doubleblind, Randomized, Controlled Trial
• Date of first enrolment: January 21, 2016
• Target sample size: 239
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02670863
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Philippines

Contacts

• Name: Elvira M Estorninos, MD
• Affiliation: Asian Hospital and Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written Informed Consent

- Infants whose parent(s)/LAR have reached the legal age of majority in the Philippines

- Infants whose parent(s)/LAR are willing and able to comply with study requirements

- Infants whose parent(s)/LAR are able to be contacted by telephone throughout the study

- Healthy term, singleton infant at birth

- Between 21 to 26 days post-natal age at enrollment visit

- Weight-for-length and head circumference-for-age z-scores >/= - 3 and to WHO Child Growth Standards

- Infants of parent(s)/LAR who have previously made the decision to formula feed their
infant at the time of enrollment

Exclusion Criteria:

- Infants with conditions requiring infant feedings other than those specified in the
protocol

- Infants receiving complementary foods or liquids

- 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

- Infants who are presently receiving or have received medications that could interfere
with the interpretation of study results

- Infants or infants whose parents/LAR cannot be expected to comply with the protocol or
with study procedures



Age minimum: N/A
Age maximum: 26 Days
Gender: All

Health Condition(s) or Problem(s) studied

Infant Term Birth

Intervention(s)

Other: Standard Infant Formula

Other: Experimental Infant Formula

Primary Outcome(s)

Stool Consistency Score [Time Frame: 150 days]

Growth [Time Frame: 150 days]

Secondary Outcome(s)

Adverse Events [Time Frame: 150 days]

Average Daily Stool Frequency [Time Frame: 150 days]

Weight [Time Frame: 150 days]

Fecal Markers [Time Frame: 150 days]

Fecal Microbiota [Time Frame: 150 days]

Secondary ID(s)

14.15.INF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors