Cow Milk Protein AllergyCMPA-GONCT06830681
CMPA-GO Study: Growth and Safety Outcomes in Infants With CMPA Fed a Novel Extensively Hydrolyzed Formula
A study testing New generation eHF and Commercial eHF in people with Cow Milk Protein Allergy, run by Société des Produits Nestlé (SPN) at 1 site in Spain.
Trial summary
CMPA-GO Study: Growth and safety Outcomes in infants with CMPA fed a novel extensively hydrolyzed formula Read more about this study
- Who is it for?
- Ages 4 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
- 4 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2025to 23 Jun 2025
- 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 4 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.
- Infant aged ≥29 days (>4 weeks) and <5 months (≤22 weeks).
- 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.
- Demonstrated chronic malabsorption not due to CMPA.
- History of anaphylaxis to CMP.
- Participants with a history of confirmed Food Protein-induced Enterocolitis Syndrome (FPIES) or Heiner syndrome.
- Any contraindication to the open OFC (eg. unstable respiratory disease), or any disorder in which epinephrine is contraindicated.
- History of any immunotherapy for CMPA.
- 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 subject's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Growth, Tolerability, and Safety Study of a Novel Extensively Hydrolyzed Formula (eHF) in Infants With Cow's Milk Protein Allergy (CMPA)
CMPA-GO Study: 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.
Growth
To assess the growth by body weight (in g), body length (in cm) and head circumference (in cm) of infants fed with the Test formula, compared to infants fed with the Control formula over 16 weeks of formula use.
Measured: 16 weeks
Secondary outcomes (5)
Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)
Data gathered by monitoring adverse events with relatedness, seriousness, and severity over 52 weeks.
Measured: 52 weeks
Tolerability
Tolerability of the formulas assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) and and Cow's Milk-related Symptom Score (CoMiSS®).
Measured: 52 weeks
Growth
The growth by body weight (in g), body length (in cm) and head circumference (in cm) of infants over 52 weeks.
Measured: 52 weeks
Stool frequency and characteristics
Stool frequency and characteristics over 52 weeks based on Brussels Infant and Toddler Stool Scale (BITSS).
Measured: 52 weeks
Quality of life
Quality of life over 52-weeks assessed by by 2 validated QoL scales ("Infant and Toddler Quality of Life" [ITQOL] and 'Food hypersensitivity famiLy ImPact' [FLIP]).
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 Feb 2025
- Study start7 Jan 2025
- Primary completion23 May 2025
- Study completion23 Jun 2025
Why it stopped: Business decision/strategic reason
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
- 4 participants (actual)
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
- NCT06830681
- Sponsor's protocol ID
- 2317.CLI
- Acronym
- CMPA-GO
- Status last verified
- Jun 2025
- First submitted
- 15 Jan 2025
- Last updated
- 29 Jun 2025
- 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 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Growth, Tolerability, and Safety Study of a Novel Extensively Hydrolyzed Formula (eHF) in Infants With Cow's Milk Protein Allergy (CMPA)
- ClinicalTrials.gov ID
- NCT06830681
- Acronym / sponsor ID
- CMPA-GO / 2317.CLI
- Conditions
- Cow Milk Protein Allergy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision/strategic reason
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 17 Feb 2025 (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.
CMPA-GO Study: 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
- 4 to 22 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Full term infant (gestational age ≥37 weeks and ≤42 weeks).
- Birth weight ≥2500 g and ≤4500 g.
- Infant aged ≥29 days (>4 weeks) and <5 months (≤22 weeks).
- 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.
Key exclusion criteria (7 listed)
- Prior use of eHF, HRF or AAF for more than 2 weeks before randomization.
- Demonstrated chronic malabsorption not due to CMPA.
- History of anaphylaxis to CMP.
- Participants with a history of confirmed Food Protein-induced Enterocolitis Syndrome (FPIES) or Heiner syndrome.
- Any contraindication to the open OFC (eg. unstable respiratory disease), or any disorder in which epinephrine is contraindicated.
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
Growth
Time frame: 16 weeks
To assess the growth by body weight (in g), body length (in cm) and head circumference (in cm) of infants fed with the Test formula, compared to infants fed with the Control formula over 16 weeks of formula use.
5 secondary outcomes
Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 52 weeks
Tolerability
Time frame: 52 weeks
Growth
Time frame: 52 weeks
Stool frequency and characteristics
Time frame: 52 weeks
Quality of life
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: Business decision/strategic reason). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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) at 1 site in Spain.
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 5 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: stopped early, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 was stopped early (reason given: Business decision/strategic reason). Results are not available in the source record.
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?
Growth (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 29 Jun 2025.