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Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants

NCT05868408 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2025-12-19

No results posted yet for this study

Summary

This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.

Conditions

  • Infant Nutritional Physiological Phenomena
  • Infant Formula
  • Infant Health
  • Infant Development
  • Growth and Development

Interventions

OTHER

Control Formula

Infant formula made with intact protein - minimum 1.8g protein/100kcal

OTHER

Experimental Formula 1

Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal

OTHER

Experimental Formula 2

Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • Saudi Arabia

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 NCT05868408 on ClinicalTrials.gov