Cow Milk Protein AllergyNCT07711938
Growth And Safety Outcomes In Infants With Cow´s Milk Protein Allergy (CMPA) Fed A Novel Extensively Hydrolyzed Formula (eHF)
A study testing New generation eHF and Commercial eHF in people with Cow Milk Protein Allergy, run by Société des Produits Nestlé (SPN).
Trial summary
Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula. Read more about this study
- Who is it for?
- Ages 29 days to 22 weeks
- Conditions the study is for
- Cow Milk Protein Allergy
- What is being tested?
- New generation eHF and Commercial eHF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 May 2029
- 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 29 days to 22 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Full-term infant(gestational age ≥37 weeks and ≤42 weeks).
- Birth weight ≥2500 g and ≤4500 g.
- Parent(s)/LAR deemed able to provide written informed consent for participation of their infant in the study (in the opinion of the investigator).
- Participant aged ≥29 days (>4 weeks) and <5 months (≤22 weeks) at time of enrollment.
- Not breastfed at time of Screening Visit.
- History of an immediate-type (IgE-mediated) allergic reaction to a cow's milk-containing food or at least 2 persistent severe symptoms suggestive of delayed-onset (non-IgE-mediated) CMPA.
Who cannot join
- Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
- Congenital illness or malformation that may affect growth, or significant pre-natal and/or serious post-natal disease other than CMPA before randomization (per investigator's medical decision).
- Demonstrated chronic malabsorption not due to CMPA.
- History of severe anaphylaxis to CMP.
- Infants whose parent(s)/LAR cannot be expected to comply with study procedures.
- Currently participating or having participated in another clinical study since birth.
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- Infants with a history of confirmed food protein induced enterocolitis syndrome due to other foods than CMP or Heiner syndrome.
- Infants with history of oral immunotherapy for CMPA.
- Diagnosed eosinophilic esophagitis.
- Received systemic oral or injected corticosteroids for more than 3 days (72 hours) within 2 weeks prior to the Screening Visit (topical corticosteroids allowed).
- Received systemic antibiotics within 1 week prior to Screening Visit (topical antibiotics, e.g., mupirocin allowed).
- Infants who are currently receiving treatment with immunomodulators (immunoglobulins, allergen extracts, or similar) or immuno-suppressants (azathioprine, cyclosporine or similar) within 2 weeks of Screening Visit (topical cyclosporine, tacrolimus, pimecrolimus or similar topical eczema treatments allowed), as well as infants with immune disorders which can compromise the immune function.
- Infants with a past or current disease or disorder which, in the opinion of the investigator or the sponsor either places the participant at risk because of participating in the study or may influence the results of the study, or the participant's ability to participate in the study (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine or metabolic disorders, malignancy, major physical impairment, immunodeficiency, infectious disease or abnormal laboratory results as per the investigator's judgment).
- Parent(s)/LAR being in any relationship or dependency with the sponsor, and/or the investigator, and/or study staff.
- Underage parents (under 18 years old).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Controlled Study to Compare Growth, Tolerability, and Safety of a Novel, Extensively Hydrolyzed Formula (eHF) Versus a Standard eHF in Full Term Infants With Cow's Milk Protein Allergy (CMPA)
Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula.
- Conditions
- Cow Milk Protein Allergy
- Being tested
- New generation eHF, Commercial eHF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New generation eHFDietary supplement
New generation of a whey-based eHF formula intended for the dietary management of infants with CMPA.
Commercial eHFDietary supplement
Commercial whey-based eHF formula intended for the dietary management of infants with CMPA.
| Study group | Role | What they receive |
|---|---|---|
| Test Formula | Experimental | New generation eHF Receives: Dietary Supplement: New generation eHF |
| Control Formula | Active comparator | Commercial eHF Receives: Dietary Supplement: Commercial eHF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain Over 16 Weeks
To demonstrate non-inferiority in growth in infants fed with the Test formula, compared to infants fed with the Control formula over the first 16 weeks of formula intake.
Measured: 16 weeks
Secondary outcomes (13)
Incidence of Adverse Events of Special Interest (AESIs)
To evaluate the safety and tolerability of the Test formula, including effects on "adverse events of special interest (AESIs)", which include lower respiratory tract infections (LRTIs), upper respiratory tract infections (URTIs), ear infections/otitis media, gastrointestinal infections and other viral or bacterial infections including urinary tract infections (UTIs).
Measured: 52 weeks
Growth Parameters: Weight
The growth by body weight (in g) of infants over 52 weeks.
Measured: 52 weeks
Growth Parameters: Length
The growth by body length (in cm) of infants over 52 weeks
Measured: 52 weeks
Quality of Life Scores (ITQOL)
Quality of life over 52-weeks assessed by validated Quality of Life (QoL) scale: Infant and Toddler Quality of Life [ITQOL]
Minimum score: 0 Maximum score: 100 Interpretation: Higher scores indicate better health-related quality of life, better functioning, or less negative impact on the child/family (depending on the specific domain). A score of 0 represents the worst health/status, while 100 represents the best health/status
Measured: 52 weeks
Stool Frequency and Stool Characteristics (BITSS)
Stool frequency and characteristics over 52 weeks based on Brussels Infant and Toddler Stool Scale (BITSS).
Scale categories: 7 stool photographs corresponding to stool consistency types
BITSS photographs are often grouped into:
Hard: Types 1-3 Formed: Type 4 Loose: Types 5-6 Watery: Type 7
Interpretation:
Lower categories (1-3): harder stools, potentially associated with constipation.
Middle category (4): formed/normal stool consistency. Higher categories (5-7): increasingly loose to watery stools, potentially associated with diarrhea.
Measured: 52 weeks
Resolution of CMPA-Related Symptoms
Rate of adequate clinical response and time to symptom resolution of CMPA-related symptoms (in days) collected on patient-reported outcome tool (PRO) based on parent(s)/legally authorized representative(s) (LAR) report.
Measured: 52 weeks
Formula intake compliance
Formula intake (in ml) compliance (number of feeds per day) based on parent(s)/LAR report records collected via electronic data capture (EDC)/interactive response technology (IRT).
Measured: 52 weeks
Healthcare resources utilization
Healthcare Resources Utilization (HCRU) over the 52-week intervention period, based on parent(s)/LAR report and medical records (such as: number of hospitalizations, number of unscheduled emergency department attendances, general practitioner/pediatrician visits)
Measured: 52 weeks
Growth Parameters: Head Circumference
The growth by head circumference (in cm) of infants over 52 weeks
Measured: 52 weeks
Quality of Life Scores (FLIP)
Quality of life over 52-weeks assessed by validated QoL scale: Food hypersensitivity family Impact [FLIP]
Lower categories (1-3): harder stools, potentially associated with constipation.
Middle category (4): formed/normal stool consistency. Higher categories (5-7): increasingly loose to watery stools, potentially associated with diarrhea.
Measured: 52 weeks
Resolution of Cow Milk Protein Allergy (CMPA)-Related Symptoms
Rate of adequate clinical response and time to symptom resolution of CMPA-related symptoms (in days) collected on Scoring Atopic Dermatitis Eczema Score (SCORAD) Minimum score: 0 Maximum score: 103 Interpretation: Higher scores indicate more severe eczema and therefore a worse outcome. Lower scores indicate less severe disease and a better outcome
Measured: 52 weeks
Resolution of CMPA-Related Symptoms
Rate of adequate clinical response and time to symptom resolution of CMPA-related symptoms (in days) collected on Infant Gastrointestinal Symptom Questionnaire (IGSQ) Minimum score: 13 Maximum score: 65 Interpretation: Higher scores indicate more gastrointestinal symptoms and poorer feeding tolerance (worse outcome). Lower scores indicate fewer GI symptoms and better tolerance.
Measured: 52 weeks
Resolution of CMPA-Related Symptoms
Rate of adequate clinical response and time to symptom resolution of CMPA-related symptoms (in days) collected on Cow's Milk-Related Symptom Score (CoMiSS).
Minimum score: 0 Maximum score: 33 Interpretation: Higher scores indicate more severe cow's milk-related symptoms and therefore a worse outcome. Lower scores indicate fewer symptoms and a better outcome.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk Protein AllergyStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 410 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
- NCT07711938
- Sponsor's protocol ID
- 2508.CLI
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled Study to Compare Growth, Tolerability, and Safety of a Novel, Extensively Hydrolyzed Formula (eHF) Versus a Standard eHF in Full Term Infants With Cow's Milk Protein Allergy (CMPA)
- ClinicalTrials.gov ID
- NCT07711938
- Acronym / sponsor ID
- 2508.CLI
- Conditions
- Cow Milk Protein Allergy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 17 Jul 2026 (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.
Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Formula | Experimental | Dietary Supplement: New generation eHFNew generation eHF |
| Control Formula | Active comparator | Dietary Supplement: Commercial eHFCommercial eHF |
Who may qualify
- Ages
- 29 days to 22 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Full-term infant(gestational age ≥37 weeks and ≤42 weeks).
- Birth weight ≥2500 g and ≤4500 g.
- Parent(s)/LAR deemed able to provide written informed consent for participation of their infant in the study (in the opinion of the investigator).
- Participant aged ≥29 days (>4 weeks) and <5 months (≤22 weeks) at time of enrollment.
- Not breastfed at time of Screening Visit.
Key exclusion criteria (15 listed)
- Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
- Congenital illness or malformation that may affect growth, or significant pre-natal and/or serious post-natal disease other than CMPA before randomization (per investigator's medical decision).
- Demonstrated chronic malabsorption not due to CMPA.
- History of severe anaphylaxis to CMP.
- Infants whose parent(s)/LAR cannot be expected to comply with study procedures.
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 |
|---|---|---|
| New generation eHFNew generation of a whey-based eHF formula intended for the dietary management of infants with CMPA. | Dietary supplement | Test Formula |
| Commercial eHFCommercial whey-based eHF formula intended for the dietary management of infants with CMPA. | Dietary supplement | Control Formula |
Primary outcome
Weight Gain Over 16 Weeks
Time frame: 16 weeks
To demonstrate non-inferiority in growth in infants fed with the Test formula, compared to infants fed with the Control formula over the first 16 weeks of formula intake.
13 secondary outcomes
Incidence of Adverse Events of Special Interest (AESIs)
Time frame: 52 weeks
Growth Parameters: Weight
Time frame: 52 weeks
Growth Parameters: Length
Time frame: 52 weeks
Quality of Life Scores (ITQOL)
Time frame: 52 weeks
Stool Frequency and Stool Characteristics (BITSS)
Time frame: 52 weeks
Resolution of CMPA-Related Symptoms
Time frame: 52 weeks
Formula intake compliance
Time frame: 52 weeks
Healthcare resources utilization
Time frame: 52 weeks
Growth Parameters: Head Circumference
Time frame: 52 weeks
Quality of Life Scores (FLIP)
Time frame: 52 weeks
Resolution of Cow Milk Protein Allergy (CMPA)-Related Symptoms
Time frame: 52 weeks
Resolution of CMPA-Related Symptoms
Time frame: 52 weeks
Resolution of CMPA-Related Symptoms
Time frame: 52 weeks
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 17 Jul 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing New generation eHF and Commercial eHF in people with Cow Milk Protein Allergy, run by Société des Produits Nestlé (SPN).
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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Kamila Laskowska (41 21 785 87 32, kamila.laskowska@rd.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Gain Over 16 Weeks (time frame: 16 weeks). 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 17 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.