Infant Nutritional Physiological PhenomenaNCT05868408
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
A study testing Experimental Formula 1 and Experimental Formula 2 in people with Infant Nutritional Physiological Phenomena and Infant Formula, run by Société des Produits Nestlé (SPN) at 5 sites in 2 countries.
Trial summary
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants. Read more about this study
- Who is it for?
- Ages 0 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Nutritional Physiological Phenomena, Infant Formula, Infant Health
- What is being tested?
- Experimental Formula 1 and Experimental Formula 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 17 Aug 2023to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent has been obtained from at least one parent (or other legally acceptable representative [LAR]), if applicable)
- Infant gestational age ≥37 completed weeks
- Infant birth weight of ≥2.5 kg and ≤4.5 kg
- Singleton birth
- 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).
- Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
- 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
Who cannot join
- Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
- Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
- Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)
- Infants with special dietary needs other than standard infant formula
- Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet
- Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
- Currently participating or having participated in another interventional clinical trial prior to enrollment
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Saudi Arabia3 sites
- Active, not recruiting
National Guard Hospital
Jeddah
- Completed
King Faisal Specialist Hospital and Research Center
Riyadh
- Completed
National Guard Hospital
Riyadh
Philippines2 sites, 2 recruiting
- Recruiting
Biomedical Research Institute
Cavite City
Edison Alberto, MD, +639171490841, edisonalberto@rocketmail.com
- Recruiting
Biomedical Research Institute
Las Piñas
Mitzi Trinidad-Aseron, MD, +639178127781, mitzi3nidad@gmail.com
About this study
Official title: 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.
- Conditions
- Infant Nutritional Physiological Phenomena, Infant Formula, Infant Health, Infant Development, Growth and Development
- Being tested
- Control Formula, Experimental Formula 1, Experimental Formula 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control FormulaOther
Infant formula made with intact protein - minimum 1.8g protein/100kcal
Experimental Formula 1Other
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
Experimental Formula 2Other
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
| Study group | Role | What they receive |
|---|---|---|
| Control formula | Active comparator | CTRL, an infant formula with minimum protein content of 1.8g intact protein/100kcal Receives: Other: Control Formula |
| Experimental formula 1 | Experimental | EXPL1, an infant formula with minimum protein content of 1.9g hydrolyzed protein/100kcal Receives: Other: Experimental Formula 1 |
| Experimental formula 2 | Experimental | EXPL2, an infant formula identical to EXPL1 but manufactured using a different partially hydrolyzed milk protein base Receives: Other: Experimental Formula 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in growth in first 4 months of life between control and experimental groups
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).
Measured: From enrollment to age 4 months
Equivalence in growth in first 4 months of life in experimental groups
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).
Measured: From enrollment to age 4 months
Secondary outcomes (12)
Gastrointestinal (GI) tolerance
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.
Measured: Enrollment and age 4, 6, and 12 months
Stooling pattern
Stool frequency and consistency assessed using a 3-day infant stool diary.
Measured: Age 2 and 4 months
Atopic dermatitis severity
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.
Measured: Enrollment and age 4, 6, and 12 months
Allergy-related symptoms
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.
Measured: Enrollment and age 4, 6, and 12 months
Dietary intake
Total energy and macronutrient intake calculated from food recalls / diaries
Measured: Age 6 months
Weight
Weight (g)
Measured: Enrollment and age 1, 2, 3, 4, and 6 months
Length
Length (cm)
Measured: Enrollment and age 1, 2, 3, 4, and 6 months
Head circumference
Head circumference (cm)
Measured: Enrollment and age 1, 2, 3, 4, and 6 months
Weight-for-age z-score
Weight-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Measured: Enrollment and age 1, 2, 3, 4, and 6 months
Weight-for-length z-score
Weight-for-length z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Measured: Enrollment and age 1, 2, 3, 4, and 6 months
Length-for-age z-score
Length-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Measured: Enrollment and age 1, 2, 3, 4, and 6 months
Head circumference-for-age z-score
Head circumference-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Measured: Enrollment and age 1, 2, 3, 4, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start17 Aug 2023
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Nutritional Physiological PhenomenaStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized, controlled, multi-arm trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868408
- Sponsor's protocol ID
- 21.10.INF
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2023
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial
- ClinicalTrials.gov ID
- NCT05868408
- Acronym / sponsor ID
- 21.10.INF
- Conditions
- Infant Nutritional Physiological Phenomena, Infant Formula, Infant Health, Infant Development, Growth and Development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blind, randomized, controlled, multi-arm trial
| Arm | Type | Receives |
|---|---|---|
| Control formula | Active comparator | Other: Control FormulaCTRL, an infant formula with minimum protein content of 1.8g intact protein/100kcal |
| Experimental formula 1 | Experimental | Other: Experimental Formula 1EXPL1, an infant formula with minimum protein content of 1.9g hydrolyzed protein/100kcal |
| Experimental formula 2 | Experimental | Other: Experimental Formula 2EXPL2, an infant formula identical to EXPL1 but manufactured using a different partially hydrolyzed milk protein base |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Written informed consent has been obtained from at least one parent (or other legally acceptable representative [LAR]), if applicable)
- Infant gestational age ≥37 completed weeks
- Infant birth weight of ≥2.5 kg and ≤4.5 kg
- Singleton birth
- 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).
Key exclusion criteria (7 listed)
- Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
- Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
- Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)
- Infants with special dietary needs other than standard infant formula
- Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control FormulaInfant formula made with intact protein - minimum 1.8g protein/100kcal | Other | Control formula |
| Experimental Formula 1Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal | Other | Experimental formula 1 |
| Experimental Formula 2Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal | Other | Experimental formula 2 |
Primary outcome
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).
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).
12 secondary outcomes
Gastrointestinal (GI) tolerance
Time frame: Enrollment and age 4, 6, and 12 months
Stooling pattern
Time frame: Age 2 and 4 months
Atopic dermatitis severity
Time frame: Enrollment and age 4, 6, and 12 months
Allergy-related symptoms
Time frame: Enrollment and age 4, 6, and 12 months
Dietary intake
Time frame: Age 6 months
Weight
Time frame: Enrollment and age 1, 2, 3, 4, and 6 months
Length
Time frame: Enrollment and age 1, 2, 3, 4, and 6 months
Head circumference
Time frame: 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-length z-score
Time frame: 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
Head circumference-for-age z-score
Time frame: Enrollment and age 1, 2, 3, 4, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Formula 1 and Experimental Formula 2 in people with Infant Nutritional Physiological Phenomena and Infant Formula, run by Société des Produits Nestlé (SPN) at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Saudi Arabia, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiaoji Li (+861087419794, qiaoji.li@rd.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in growth in first 4 months of life between control and experimental groups (time frame: From enrollment to age 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.