GrowthNCT05047978
Growth and Tolerance of a Partially Hydrolyzed Infant Formula
A study testing Cow's milk protein infant formula and Partially hydrolyzed protein infant formula in people with Growth, run by Mead Johnson Nutrition at 13 sites in United States.
Trial summary
The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age. Read more about this study
- Who is it for?
- Ages 10 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Cow's milk protein infant formula and Partially hydrolyzed protein infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 13 sitesUnited States
- Study dates
- 28 Aug 2021to 21 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 10 to 14 days of age at randomization
- singleton birth
- Gestational age of 37 to 42 weeks
- Birth weight of 2500 g (5lbs 8oz or more)
- Exclusively receiving infant formula for at least 24 hours prior to randomization
- Parent or legal guardian has full intention to exclusively feed study formula through 120 days of age
- Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
- Signed informed consent and authorization to use and disclose Protected Health information
Who cannot join
- History of underlying metabolic or chronic disease
- Evidence of feeding difficulties or history of formula intolerance
- Weight at Visit 1 is <98% of birth weight
- Infant was born large for gestational age from a mother who was diabetic at childbirth
- Infant is immunocompromised
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Birmingham Pediatric Associates
Birmingham, Alabama, 35205
Southeastern Pediatric Associates
Dothan, Alabama, 36305
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, 72703
Meridian Clinical Research
Grand Island, Nebraska, 68803
The Jackson Clinic
Jackson, Tennessee, 38305
The Children's Clinic of Jonesboro
Jonesboro, Arkansas, 72401
DCOL Center for Clinical Research
Longview, Texas, 75605
PAS Research
McAllen, Texas, 78501
Saltzer Health
Nampa, Idaho, 83686
Springs Medical Research
Owensboro, Kentucky, 42303
PAS Research
Tampa, Florida, 33613
Visions Clinical Research-Tucson
Tucson, Arizona, 85712
Rophe Adult & Pediatric Medicine
Union City, Georgia, 30339
About this study
Official title: Growth and Tolerance of a Partially Hydrolyzed Cow's Milk Protein (PHP) Infant Formula
The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.
- Conditions
- Growth
- Being tested
- Cow's milk protein infant formula, Partially hydrolyzed protein infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cow's milk protein infant formulaOther
A routine cow's milk-based infant formula
Partially hydrolyzed protein infant formulaOther
A partially hydrolyzed cow's milk protein (PHP) infant formula
| Study group | Role | What they receive |
|---|---|---|
| A routine cow's milk-based infant formula | Active comparator | A routine cow's milk-based infant formula Receives: Other: Cow's milk protein infant formula |
| A partially hydrolyzed cow's milk protein (PHP) infant formula | Experimental | A partially hydrolyzed cow's milk protein (PHP) infant formula Receives: Other: Partially hydrolyzed protein infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of body weight gain
Measured: up to 120 days
Secondary outcomes (13)
Body length
Measured: up to 365 days of age
Head circumference
Measured: up to 365 days of age
Growth Z scores
weight-for-age
Measured: up to 365 days of age
Growth Z scores
length-for-age
Measured: up to 365 days of age
Growth Z scores
head circumference-for-age
Measured: up to 365 days of age
Recall of study formula intake measured at each study visit
questionnaire
Measured: up to 365 days of age
Recall of stool characteristics measured at each study visit
questionnaire
Measured: up to 365 days of age
Pediatric Quality of Life Family Impact Module
questionnaire
Measured: up to 365 days of age
Pediatric Quality of Life Inventory Infant Scales
Questionnaire. A 5-point response scale is utilized (0 = never a problem; 4 = always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact).
Measured: 120, 180, 275, and 365 days of age
Medically confirmed adverse events collected throughout the study period
Measured: up to 365 days of age
Specific medically confirmed adverse events related to gastrointestinal
Measured: up to 365 days of age
Specific medically confirmed adverse events related to allergy
Measured: up to 365 days of age
Body weight
Measured: up to 365 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start28 Aug 2021
- Primary completion11 Oct 2022
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GrowthStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Wu, Medical Director, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047978
- Sponsor's protocol ID
- 3391-1
- Status last verified
- Jan 2024
- First submitted
- 8 Sep 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fabrizio V, Abdelmagid SA, Bose A, Hale M, Hays EC, Hudson M, Hughes T, Leonard D, Rouse K, Sideri M, Walker J, Wampler JL, Yeiser M, Zhuang W, Wu SS. Partially hydrolyzed cow's milk protein formula with an added prebiotic is well-tolerated, safe, and supports age-appropriate growth in healthy term infants through one year of age: DBRCT. BMC Pediatr. 2026 Jan 13;26(1):250. doi: 10.1186/s12887-025-06454-2.
PubMed 41527066
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance of a Partially Hydrolyzed Cow's Milk Protein (PHP) Infant Formula
- ClinicalTrials.gov ID
- NCT05047978
- Acronym / sponsor ID
- 3391-1
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 17 Sep 2021 (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.
The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A routine cow's milk-based infant formula | Active comparator | Other: Cow's milk protein infant formulaA routine cow's milk-based infant formula |
| A partially hydrolyzed cow's milk protein (PHP) infant formula | Experimental | Other: Partially hydrolyzed protein infant formulaA partially hydrolyzed cow's milk protein (PHP) infant formula |
Who may qualify
- Ages
- 10 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 10 to 14 days of age at randomization
- singleton birth
- Gestational age of 37 to 42 weeks
- Birth weight of 2500 g (5lbs 8oz or more)
- Exclusively receiving infant formula for at least 24 hours prior to randomization
Key exclusion criteria (5 listed)
- History of underlying metabolic or chronic disease
- Evidence of feeding difficulties or history of formula intolerance
- Weight at Visit 1 is <98% of birth weight
- Infant was born large for gestational age from a mother who was diabetic at childbirth
- Infant is immunocompromised
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 |
|---|---|---|
| Cow's milk protein infant formulaA routine cow's milk-based infant formula | Other | A routine cow's milk-based infant formula |
| Partially hydrolyzed protein infant formulaA partially hydrolyzed cow's milk protein (PHP) infant formula | Other | A partially hydrolyzed cow's milk protein (PHP) infant formula |
Primary outcome
Rate of body weight gain
Time frame: up to 120 days
13 secondary outcomes
Body length
Time frame: up to 365 days of age
Head circumference
Time frame: up to 365 days of age
Growth Z scores
Time frame: up to 365 days of age
Growth Z scores
Time frame: up to 365 days of age
Growth Z scores
Time frame: up to 365 days of age
Recall of study formula intake measured at each study visit
Time frame: up to 365 days of age
Recall of stool characteristics measured at each study visit
Time frame: up to 365 days of age
Pediatric Quality of Life Family Impact Module
Time frame: up to 365 days of age
Pediatric Quality of Life Inventory Infant Scales
Time frame: 120, 180, 275, and 365 days of age
Medically confirmed adverse events collected throughout the study period
Time frame: up to 365 days of age
Specific medically confirmed adverse events related to gastrointestinal
Time frame: up to 365 days of age
Specific medically confirmed adverse events related to allergy
Time frame: up to 365 days of age
Body weight
Time frame: up to 365 days of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Derived from this study: PubMed 41527066Fabrizio V, Abdelmagid SA, Bose A, Hale M, Hays EC, Hudson M, Hughes T, Leonard D, Rouse K, Sideri M, Walker J, Wampler JL, Yeiser M, Zhuang W, Wu SS. Partially hydrolyzed cow's milk protein formula with an added prebiotic is well-tolerated, safe, and supports age-appropriate growth in healthy term infants through one year of age: DBRCT. BMC Pediatr. 2026 Jan 13;26(1):250. doi: 10.1186/s12887-025-06454-2.
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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. This study is not recruiting at the moment.
Steven Wu, Medical Director study director
Mead Johnson Nutrition
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cow's milk protein infant formula and Partially hydrolyzed protein infant formula in people with Growth, run by Mead Johnson Nutrition at 13 sites in United States.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of body weight gain (time frame: up to 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05047978, which also lists 1 linked publication.
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 23 Jan 2024.