Actively Recruiting

Phase Not Applicable
Age: 0Days - 28Days
All Genders
Healthy Volunteers
NCT05868408

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

Led by Société des Produits Nestlé (SPN) · Updated on 2025-12-19

234

Participants Needed

3

Research Sites

250 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Days - 28Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent obtained from parent or legal representative
  • Infant born at 37 or more completed weeks gestation
  • Infant birth weight between 2.5 kg and 4.5 kg
  • Singleton birth
  • Infant is 28 days old or younger
  • Mother has decided to fully formula-feed and infant is no longer breastfeeding or receiving breast milk
  • Parent or legal representative is of legal adult age, understands study documents, and can comply with study requirements
Not Eligible

You will not qualify if you...

  • Chronic infectious, metabolic, genetic illness or other disease affecting feeding or growth
  • Major congenital or chromosomal abnormalities affecting growth (e.g., congenital heart disease, cystic fibrosis)
  • Maternal medical conditions affecting infant growth (e.g., untreated preeclampsia, gestational diabetes)
  • Infants requiring special dietary needs other than standard formula
  • Known or suspected cow's milk protein intolerance or allergy, lactose intolerance, or severe food allergies affecting diet
  • Other medical or psychiatric conditions making participation unsuitable as judged by the investigator
  • Current or previous participation in another interventional clinical trial before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

National Guard Hospital

Jeddah, Saudi Arabia

Actively Recruiting

2

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

Completed

3

National Guard Hospital

Riyadh, Saudi Arabia

Active, Not Recruiting

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Research Team

A

Anthony de Cozar

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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