Milk AllergyNCT02317952
Formula for Children With Cow's Milk Allergy
A study testing Experimental Extensively Hydrolyzed Formula and Active Comparator Formula in people with Milk Allergy, run by Perrigo Nutritionals at 18 sites in United States.
Trial summary
The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy. Read more about this study
- Who is it for?
- Ages Up to 13 years
- Conditions the study is for
- Milk Allergy
- What is being tested?
- Experimental Extensively Hydrolyzed Formula and Active Comparator Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 18 sitesUnited States
- Study dates
- May 2014to Dec 2016
- 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 Up to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Good health
- Parent/guardian must be willing to provide informed consent
- Parent/guardian agrees to feed study formula provided
- Confirmation of Cow's Milk Allergy
Who cannot join
- No clinically significant abnormal findings on medical history, laboratory results, and physical exam.
- No medications that may interfere with or impact evaluation of the study assessments
- Allergy to extensively hydrolyzed casein formula
- Tolerance of 200 ml of cow's milk, cow's milk-based formula or food products containing intact cow's milk protein within 2 weeks of the Screening Visit
- Participation in another clinical trial within 30 days of screening where they are are receiving an active intervention
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Clinical Research Center of Alabama
Birmingham, Alabama, 35209
TTS Research
Boerne, Texas, 78006
1st Allergy and Clinical Research Group, INC, d/b/a IMMUNOe International Research Centers
Centennial, Colorado, 80112
Institute for Allergy and Asthma
Chevy Chase, Maryland, 20815
Pediatric Care Medical Group
Huntington Beach, California, 92647
Arkansas Children's Hosptial
Little Rock, Arkansas, 72202
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Clinical Research Solutions, LLC
Middleburg Heights, Ohio, 44130
Sneeze Wheeze and Itch Associates
Normal, Illinois, 61761
Allergy, Asthma, and Clinical Research Center
Oklahoma City, Oklahoma, 73120
Choc Psf, Amc
Orange, California, 92868
Carolina Ear Nose and Throat Clinic
Orangeburg, South Carolina, 29118
Clinical Research Institute
Plymouth, Minnesota, 55441
Allergy Medical Group of the North Area, INC
Roseville, California, 95678
STAAMP Clinical Research
San Antonio, Texas, 78251
Allergy & Asthma Medical Group and Research Center, APC
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
Einstein Consulting Services, LLC & Virgo Carter Pediatrics
Silver Spring, Maryland, 20910
About this study
Official title: A Double-Blind, Randomized, Crossover Allergy Study of an Experimental Formula Followed by a 16 Week Double Blind Feeding Period to Assess Growth, Safety and Development of Tolerance to Cow's Milk Protein
The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy.
- Conditions
- Milk Allergy
- Being tested
- Experimental Extensively Hydrolyzed Formula, Active Comparator 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.
Experimental Extensively Hydrolyzed FormulaOther
Active Comparator FormulaOther
| Study group | Role | What they receive |
|---|---|---|
| New Extensively Hydrolyzed Formula | Experimental | Administered in context of oral food challenge and then for 16 weeks. Receives: Other: Experimental Extensively Hydrolyzed Formula |
| Comparator Formula | Active comparator | Administered in context of oral food challenge and then for 16 weeks. Receives: Other: Active Comparator Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Allergic Reaction
Measured: 2 weeks
Secondary outcomes (2)
Growth
Anthropometric measurements of weight in all enrolled subjects.
Measured: 16 weeks
Growth
Anthropometric measurements of length/height in all enrolled subjects.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Milk AllergyStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perrigo Nutritionals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cindy M Barber, PhD, Study director, Perrigo Nutritionals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317952
- Sponsor's protocol ID
- PRG-VA-14-001
- Status last verified
- Jun 2017
- First submitted
- 2 Dec 2014
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Crossover Allergy Study of an Experimental Formula Followed by a 16 Week Double Blind Feeding Period to Assess Growth, Safety and Development of Tolerance to Cow's Milk Protein
- ClinicalTrials.gov ID
- NCT02317952
- Acronym / sponsor ID
- PRG-VA-14-001
- Conditions
- Milk Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Perrigo NutritionalsIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Dec 2014 (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.
The purpose of this study is to determine if a new extensively hydrolyzed formula can be consumed by children with Cow's Milk Allergy.
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 |
|---|---|---|
| New Extensively Hydrolyzed Formula | Experimental | Other: Experimental Extensively Hydrolyzed FormulaAdministered in context of oral food challenge and then for 16 weeks. |
| Comparator Formula | Active comparator | Other: Active Comparator FormulaAdministered in context of oral food challenge and then for 16 weeks. |
Who may qualify
- Ages
- Up to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Good health
- Parent/guardian must be willing to provide informed consent
- Parent/guardian agrees to feed study formula provided
- Confirmation of Cow's Milk Allergy
Key exclusion criteria (5 listed)
- No clinically significant abnormal findings on medical history, laboratory results, and physical exam.
- No medications that may interfere with or impact evaluation of the study assessments
- Allergy to extensively hydrolyzed casein formula
- Tolerance of 200 ml of cow's milk, cow's milk-based formula or food products containing intact cow's milk protein within 2 weeks of the Screening Visit
- Participation in another clinical trial within 30 days of screening where they are are receiving an active intervention
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 |
|---|---|---|
| Experimental Extensively Hydrolyzed Formula | Other | New Extensively Hydrolyzed Formula |
| Active Comparator Formula | Other | Comparator Formula |
Primary outcome
Incidence of Allergic Reaction
Time frame: 2 weeks
2 secondary outcomes
Growth
Time frame: 16 weeks
Growth
Time frame: 16 weeks
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 8 Jun 2017.
Related trials for Milk Allergy
Active, not recruitingPhase 2
Phase 2b Study of RPT904 as Monotherapy in Participants With IgE-Mediated Food Allergy
Immune System Diseases, Ig-E Mediated Food Allergy
Recruiting
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
Cow's Milk Allergy
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.
Cindy M Barber, PhD study director
Perrigo Nutritionals
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Extensively Hydrolyzed Formula and Active Comparator Formula in people with Milk Allergy, run by Perrigo Nutritionals at 18 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 4 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 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Incidence of Allergic Reaction (time frame: 2 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 8 Jun 2017.