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

July 14, 2026 updated by: Société des Produits Nestlé (SPN)

Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Philippines
      • Cavite City, Philippines
      • Las Piñas, Philippines
        • Recruiting
        • Biomedical Research Institute
        • Contact:
  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • Active, not recruiting
        • National Guard Hospital
      • Riyadh, Saudi Arabia
        • Completed
        • King Faisal Specialist Hospital and Research Center
      • Riyadh, Saudi Arabia
        • Completed
        • National Guard Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative [LAR]), if applicable)
  2. Infant gestational age ≥37 completed weeks
  3. Infant birth weight of ≥2.5 kg and ≤4.5 kg
  4. Singleton birth
  5. For Saudi: Infant postnatal age ≤28 days (date of birth = day 0); For Philippines: Infant postnatal age ≥ 14 days and ≤ 28 days (date of birth = day 0).
  6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
  7. Infant's parent(s)/LAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol

Exclusion Criteria:

  1. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
  2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
  3. Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)
  4. Infants with special dietary needs other than standard infant formula
  5. Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet
  6. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
  7. Currently participating or having participated in another interventional clinical trial prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control formula
CTRL, an infant formula with minimum protein content of 1.8g intact protein/100kcal
Other: Control Formula
Infant formula made with intact protein - minimum 1.8g protein/100kcal
Experimental: Experimental formula 1
EXPL1, an infant formula with minimum protein content of 1.9g hydrolyzed protein/100kcal
Other: Experimental Formula 1
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
Experimental: Experimental formula 2
EXPL2, an infant formula identical to EXPL1 but manufactured using a different partially hydrolyzed milk protein base
Other: Experimental Formula 2
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in growth in first 4 months of life between control and experimental groups
Time Frame: From enrollment to age 4 months
To demonstrate that growth from enrollment to age 4 months of infants fed experimental formula 1 (EXPL1) or experimental formula 2 (EXPL2) is non-inferior to that of infants fed control formula (CTRL). This is measured by weight gain velocity (g/day).
From enrollment to age 4 months
Equivalence in growth in first 4 months of life in experimental groups
Time Frame: From enrollment to age 4 months
To demonstrate that growth from enrollment to age 4 months is equivalent between infants fed EXPL1 or EXPL2. This is measured by weight gain velocity (g/day).
From enrollment to age 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastrointestinal (GI) tolerance
Time Frame: Enrollment and age 4, 6, and 12 months
GI tolerance assessed using the Infant Gastrointestinal Symptom Questionnaire (IGSQ). IGSQ scores range from 13 to 65, with lower scores indicating lower GI symptom burden.
Enrollment and age 4, 6, and 12 months
Stooling pattern
Time Frame: Age 2 and 4 months
Stool frequency and consistency assessed using a 3-day infant stool diary.
Age 2 and 4 months
Atopic dermatitis severity
Time Frame: Enrollment and age 4, 6, and 12 months
Atopic dermatitis severity assessed using the Patient Oriented Eczema Measure (POEM). POEM scores range from 0 to 28, with lower scores indicating lower atopic dermatitis severity.
Enrollment and age 4, 6, and 12 months
Allergy-related symptoms
Time Frame: Enrollment and age 4, 6, and 12 months
Allergy-related symptoms assessed using the Multi-Organ System Questionnaire for Infants (MOSQ-I). MOSQ-I scores range from 0 to 105, with lower scores indicating lower allergy-related symptom burden.
Enrollment and age 4, 6, and 12 months
Dietary intake
Time Frame: Age 6 months
Total energy and macronutrient intake calculated from food recalls / diaries
Age 6 months
Weight
Time Frame: Enrollment and age 1, 2, 3, 4, and 6 months
Weight (g)
Enrollment and age 1, 2, 3, 4, and 6 months
Length
Time Frame: Enrollment and age 1, 2, 3, 4, and 6 months
Length (cm)
Enrollment and age 1, 2, 3, 4, and 6 months
Head circumference
Time Frame: Enrollment and age 1, 2, 3, 4, and 6 months
Head circumference (cm)
Enrollment and age 1, 2, 3, 4, and 6 months
Weight-for-age z-score
Time Frame: Enrollment and age 1, 2, 3, 4, and 6 months
Weight-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Enrollment and age 1, 2, 3, 4, and 6 months
Weight-for-length z-score
Time Frame: Enrollment and age 1, 2, 3, 4, and 6 months
Weight-for-length z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Enrollment and age 1, 2, 3, 4, and 6 months
Length-for-age z-score
Time Frame: Enrollment and age 1, 2, 3, 4, and 6 months
Length-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Enrollment and age 1, 2, 3, 4, and 6 months
Head circumference-for-age z-score
Time Frame: Enrollment and age 1, 2, 3, 4, and 6 months
Head circumference-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Enrollment and age 1, 2, 3, 4, and 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stool microbiota composition
Time Frame: Age 4 months
Stool microbiota composition assessed using shotgun metagenomic analysis
Age 4 months
Stool microbiota metabolism
Time Frame: Age 4 months
Stool organic acids and other metabolites
Age 4 months
Fecal peptides
Time Frame: Age 4 months
Fecal milk-derived peptides
Age 4 months
Urinary metabolomic profile
Time Frame: Age 4 months
Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy
Age 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société des Produits Nestlé (SPN)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21.10.INF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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