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Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein

NCT04880083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-02

No results posted yet for this study

Summary

This is a non-randomized, single-arm, open-label, prospective interventional study using a commercially available starter infant formula in healthy term formula-fed infants with a parallel group of healthy term breast-fed infants as reference group. Approximately 120 male and female infants (60 per group) who are 3-28 days old and are exclusively or predominately formula-feeding or breastfeeding will be enrolled.

Conditions

  • Digestion
  • Gut Microbiota

Interventions

DIETARY_SUPPLEMENT

Commercially Available Starter Infant Formula

Study formula is provided in powder form and will be administered orally, ad libitum, via an infant feeding bottle and the volume of formula offered to the infant will be guided by the recommended feeding table for the age group or by physician recommendation. The amount consumed by the infant will vary by each infant's weight and appetite.

Sponsors & Collaborators

  • Medrio, Inc

    collaborator UNKNOWN

  • SAS Institute

    collaborator INDUSTRY

  • Veeva Systems

    collaborator INDUSTRY

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Principal Investigators

  • Ying Wang · Shanghai Institute for Pediatric Research at Xinhua Hospital, Shanghai Jiao Tong University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2022-12-28
Completion
2022-12-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880083 on ClinicalTrials.gov