Cow Milk AllergyNCT03236207
Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
A study testing Test extensively hydrolyzed formula in people with Cow Milk Allergy, run by Société des Produits Nestlé (SPN) at 12 sites in United States.
Trial summary
Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days. Read more about this study
- Who is it for?
- Ages 2 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- Test extensively hydrolyzed formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 12 sitesUnited States
- Study dates
- 6 Jul 2017to 6 Nov 2018
- 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 2 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born at term (>36 weeks gestation)
- 2 months to <4 years of age at enrollment
- Documented CMA within 6 months prior to enrollment
- Otherwise healthy
- Having obtained his/her legal representative's informed consent
Who cannot join
- Children consuming mother's milk at the time of inclusion and during the trial
- Any chromosomal or major congenital anomalies
- Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
- Immunodeficiency
- Anaphylaxis to any food
- Receiving free amino acid formula
- Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
- Currently participating in another clinical trial
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Breathe America
Albuquerque, New Mexico, 87109
Northwell Health System
Great Neck, New York, 11021
Houston Clinical Research Associates
Houston, Texas, 77090
Hoag Medical Group
Huntington Beach, California, 92648
Memphis & Shelby County Pediatrics
Memphis, Tennessee, 38116
Stanford University
Mountain View, California, 94040
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 71320
Carolina ENT
Orangeburg, South Carolina, 29118
Clinical Research Institute
Plymouth, Minnesota, 55441
Midwest Clinical Research
St Louis, Missouri, 63141
Allergy Asthma Research Institute
Waco, Texas, 76633
About this study
Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.
- Conditions
- Cow Milk Allergy
- Being tested
- Test extensively hydrolyzed formula, Control extensively hydrolyzed formula
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test extensively hydrolyzed formulaOther
extensively hydrolyzed formula with HMOs
Control extensively hydrolyzed formulaOther
extensively hydrolyzed formula without HMOs
| Study group | Role | What they receive |
|---|---|---|
| Test infant formula | Experimental | Test non-commercial extensively hydrolyzed infant formula with HMOs Receives: Other: Test extensively hydrolyzed formula |
| Control infant formula | Active comparator | Control non-commercial extensively hydrolyzed infant formula without HMOs Receives: Other: Control extensively hydrolyzed formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
allergic reaction post DBPCFC
subjects will be observed during and for at least 2 hours after the food challenge for any allergic reaction symptoms which will be documented by investigators
Measured: 2 hours
Secondary outcomes (3)
stool characteristics
collected on daily diaries
Measured: 1 week
formula intake
amount of formula ingested daily
Measured: 1 week
adverse events
adverse events as reported by caregivers
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start6 Jul 2017
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Nowak-Wegrzyn, MD, Principal investigator, Mt Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236207
- Sponsor's protocol ID
- 16.16.CLI
- Status last verified
- Jan 2019
- First submitted
- 19 Jul 2017
- Last updated
- 30 Jan 2019
- 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 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
- ClinicalTrials.gov ID
- NCT03236207
- Acronym / sponsor ID
- 16.16.CLI
- Conditions
- Cow Milk Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 1 Aug 2017 (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.
Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test infant formula | Experimental | Other: Test extensively hydrolyzed formulaTest non-commercial extensively hydrolyzed infant formula with HMOs |
| Control infant formula | Active comparator | Other: Control extensively hydrolyzed formulaControl non-commercial extensively hydrolyzed infant formula without HMOs |
Who may qualify
- Ages
- 2 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Born at term (>36 weeks gestation)
- 2 months to <4 years of age at enrollment
- Documented CMA within 6 months prior to enrollment
- Otherwise healthy
- Having obtained his/her legal representative's informed consent
Key exclusion criteria (8 listed)
- Children consuming mother's milk at the time of inclusion and during the trial
- Any chromosomal or major congenital anomalies
- Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
- Immunodeficiency
- Anaphylaxis to any food
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 |
|---|---|---|
| Test extensively hydrolyzed formulaextensively hydrolyzed formula with HMOs | Other | Test infant formula |
| Control extensively hydrolyzed formulaextensively hydrolyzed formula without HMOs | Other | Control infant formula |
Primary outcome
allergic reaction post DBPCFC
Time frame: 2 hours
subjects will be observed during and for at least 2 hours after the food challenge for any allergic reaction symptoms which will be documented by investigators
3 secondary outcomes
stool characteristics
Time frame: 1 week
formula intake
Time frame: 1 week
adverse events
Time frame: 1 week
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 30 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Cow Milk Allergy
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
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Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
IgE-Mediated Cow Milk Allergy
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
Milk Allergy
Recruiting
Infant Formula in Infants and Children With Cow's Milk Allergy
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RecruitingPhase 3
A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
IgE-Mediated Food Allergy, Peanut Allergy
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.
Anna Nowak-Wegrzyn, MD principal investigator
Mt Sinai
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test extensively hydrolyzed formula in people with Cow Milk Allergy, run by Société des Produits Nestlé (SPN) at 12 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 5 inclusion and 8 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
allergic reaction post DBPCFC (time frame: 2 hours). 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 30 Jan 2019.