Cow's Milk AllergyNCT02450643
Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
A study testing Test extensively hydrolyzed formula in people with Cow's Milk Allergy, run by Société des Produits Nestlé (SPN) at 8 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 years
- Conditions the study is for
- Cow's Milk Allergy
- What is being tested?
- Test extensively hydrolyzed formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2015to Jun 2017
- 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
- No healthy volunteers
- 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
- 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Allergy and Sinus Relief Center/Great Lakes Medical research
Chardon, Ohio
Atria Clinical Research
Little Rock, Arkansas
Allergy and Asthma Associates of Southern California
Mission Viejo, California
Mt. Sinai
New York, New York
ENT & Allergy Associates
Newburgh, New York
AeroAllergy
Savannah, Georgia
All Children's Hospital
St. Petersburg, Florida
Allergy Asthma Research Institute
Waco, Texas
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's 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 made with a new enzyme
Control extensively hydrolyzed formulaOther
commercially available extensively hydrolyzed formula
| Study group | Role | What they receive |
|---|---|---|
| Test then Control | Active comparator | Subjects will perform a DBPCFC with the Test formula followed by the Control formula Receives: Other: Test extensively hydrolyzed formula; Other: Control extensively hydrolyzed formula |
| Control then Test | Active comparator | Subjects will perform a DBPCFC with the Control formula followed by the Test formula Receives: Other: Test extensively hydrolyzed formula; Other: Control extensively hydrolyzed formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
allergic reaction
number of children who react during a DBPCFC to either formula
Measured: 2 hours post-DBPCFC
Secondary outcomes (3)
stool characteristics
stool descriptors as collected on daily diaries
Measured: 1 week
formula intake
amount of formula ingested as collected on daily diaries
Measured: 1 week
adverse events
any adverse event 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 posted21 May 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow's 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (estimated)
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
- NCT02450643
- Sponsor's protocol ID
- 14.24.CLI
- Status last verified
- Jul 2017
- First submitted
- 7 May 2015
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hypoallergenicity of a New Extensively Hydrolyzed Formula
- ClinicalTrials.gov ID
- NCT02450643
- Acronym / sponsor ID
- 14.24.CLI
- Conditions
- Cow's Milk Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 21 May 2015 (estimated)
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test then Control | Active comparator | Other: Test extensively hydrolyzed formula, Other: Control extensively hydrolyzed formulaSubjects will perform a DBPCFC with the Test formula followed by the Control formula |
| Control then Test | Active comparator | Other: Test extensively hydrolyzed formula, Other: Control extensively hydrolyzed formulaSubjects will perform a DBPCFC with the Control formula followed by the Test formula |
Who may qualify
- Ages
- 2 months to 4 years
- Sex
- All
- Healthy volunteers
- Not 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 (7 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
- Receiving free amino acid formula
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 made with a new enzyme | Other | Control then Test, Test then Control |
| Control extensively hydrolyzed formulacommercially available extensively hydrolyzed formula | Other | Control then Test, Test then Control |
Primary outcome
allergic reaction
Time frame: 2 hours post-DBPCFC
number of children who react during a DBPCFC to either formula
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 1 Aug 2017.
Related trials for Cow's Milk Allergy
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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.
Anna Nowak-Wegrzyn, MD principal investigator
Mt. Sinai
8 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's Milk Allergy, run by Société des Produits Nestlé (SPN) at 8 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 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: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 (time frame: 2 hours post-DBPCFC). 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 1 Aug 2017.