Food HypersensitivityNCT01278446

Extensively Hydrolyzed Formula: Hypoallergenicity

A study testing Extensively hydrolyzed, whey protein infant formula and Extensively hydrolyzed, casein protein infant formula in people with Food Hypersensitivity, run by Société des Produits Nestlé (SPN) at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic. Read more about this study

Who is it for?: Ages 2 months to 12 years
Conditions the study is for: Food Hypersensitivity
What is being tested?: Extensively hydrolyzed, whey protein infant formula and Extensively hydrolyzed, casein protein infant formula
Could I receive a placebo?: No, everyone receives an active treatment
How many people: Not given
Where: 14 sitesUnited States
Study dates: Feb 2011to Aug 2012
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 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Born at term (>36 weeks gestation)
Two (2) months to ≤ 12 years of age at enrollment
Documented Cow's Milk Allergy (CMA) within the 6 months prior to enrollment by:
Reported convincing allergic symptoms following an exposure to milk or a milk-containing food product and [detectable serum milk-specific IgE (>0.7 kIU/L) or positive skin prick test (wheal greater than 5 mm]), OR
Physician-supervised oral food challenge that elicited immediate allergic symptoms, OR
Results of laboratory tests highly predictive of clinical reactivity to milk

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Serum milk IgE ≥15 [kIU/L]or ≥ 5 [kIU/L if younger than 1 year OR,
Skin prick tests mean wheal >10 mm
Otherwise healthy
If subject has asthma, atopic dermatitis, and/or rhinitis, must be well controlled
Expected daily intake of at least 8 oz (240 ml) of the study formula during the open challenge phase
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
Any major gastrointestinal disease or abnormalities other than CMA
Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs acceptable)
Immunodeficiency
Receiving free amino acid formula

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Anti-histamine use in 7 days prior to the first food challenge (eyedrops are acceptable)
Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroids are okay)
Unstable asthma
Severe uncontrolled eczema
Recent ( within the last 3 months) severe anaphylactic reaction to milk
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

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Allergy Partners of Western North Carolina
Asheville, North Carolina, 28801
TTS Research
Boerne, Texas
Brookstone Clinical Research Center
Columbus, Georgia
Idaho Allergy and Asthma Specialists
Eagle, Idaho, 83616
Anderson & Collins Clinical Research
Edison, New Jersey
Deaconness Clinic
Evansville, Indiana
Clinical Research Partners
Henrico, Virginia
Pediatric Care Medical Group, Inc
Huntington Beach, California
Little Rock Allergy & Asthma
Little Rock, Arkansas
Mount Sinai Faculty Practice Associates Pediatric Allergy
New York, New York, 10029
ENT & Allergy Associates
Newburgh, New York
Allergy Medical Group of the North Area
Roseville, California, 95678
Aeroallergy Research Labs of Savannah
Savannah, Georgia, 31406
Advanced Pediatrics
Vienna, Virginia

Other trials in United States

About this study

Official title: Evaluation of Hypoallergenicity of a 100% Whey, Extensively Hydrolyzed Infant Formula

The primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic.

Conditions: Food Hypersensitivity
Being tested: Extensively hydrolyzed, whey protein infant formula, Extensively hydrolyzed, casein protein infant formula
Keywords: Cow's Milk Allergy, CMA
Medical subject headings: Food Hypersensitivity, Milk Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extensively hydrolyzed, whey protein infant formulaOther
Also called Baby Formula
New hydrolyzed formula
Extensively hydrolyzed, casein protein infant formulaOther
Also called Baby Formula
Commercially available hydrolyzed infant formula

Study groups in NCT01278446
Study group	Role	What they receive
Test Formula	Experimental	New hydrolyzed whey formula Receives: Other: Extensively hydrolyzed, whey protein infant formula
Control Formula	Active comparator	Commercially available hydrolyzed infant formula Receives: Other: Extensively hydrolyzed, casein protein infant formula

What is being measured

The primary outcome is the main question the study is designed to answer.

Hypoallergenicity
To demonstrate that the test formula does not provoke allergenic activity
Measured: 14 Days

Secondary outcomes (1)

Digestive Tolerance
Measured: 1 Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Aug 2012

First posted17 Jan 2011 (estimated)
Study startFeb 2011
Primary completionJun 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Food HypersensitivityStudies 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor

IDs, dates and publications

ClinicalTrials.gov ID: NCT01278446
Sponsor's protocol ID: 09.42.PED
Status last verified: Nov 2013
First submitted: 14 Jan 2011
Last updated: 4 Nov 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Oral Immunotherapy for Children With Egg Allergy
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All Food Hypersensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Hypoallergenicity of a 100% Whey, Extensively Hydrolyzed Infant Formula
ClinicalTrials.gov ID: NCT01278446
Acronym / sponsor ID: 09.42.PED
Conditions: Food Hypersensitivity
Keywords: Cow's Milk Allergy, CMA
Study type: Interventional
Recruitment status: Completed
Lead sponsor: Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Jun 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 17 Jan 2011 (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 primary objective of this clinical trial is to determine whether a new extensively hydrolyzed infant formula is hypoallergenic.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Test Formula	Experimental	Other: Extensively hydrolyzed, whey protein infant formulaNew hydrolyzed whey formula
Control Formula	Active comparator	Other: Extensively hydrolyzed, casein protein infant formulaCommercially available hydrolyzed infant formula

Who may qualify

Ages: 2 months to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (12 listed)

Born at term (>36 weeks gestation)
Two (2) months to ≤ 12 years of age at enrollment
Documented Cow's Milk Allergy (CMA) within the 6 months prior to enrollment by:
Otherwise healthy
If subject has asthma, atopic dermatitis, and/or rhinitis, must be well controlled

Key exclusion criteria (13 listed)

Children consuming mother's milk at the time of inclusion and during the trial
Any chromosomal or major congenital anomalies
Any major gastrointestinal disease or abnormalities other than CMA
Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs acceptable)
Immunodeficiency

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
Extensively hydrolyzed, whey protein infant formulaAlso: Baby FormulaNew hydrolyzed formula	Other	Test Formula
Extensively hydrolyzed, casein protein infant formulaAlso: Baby FormulaCommercially available hydrolyzed infant formula	Other	Control Formula

Primary outcome

Hypoallergenicity
Time frame: 14 Days
To demonstrate that the test formula does not provoke allergenic activity

1 secondary outcome

Digestive Tolerance
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 4 Nov 2013.

Related trials for Food Hypersensitivity

Not yet recruiting
Oral Immunotherapy for Children With Peanut Allergy
Peanut Allergic Subjects, Peanut Allergies
RecruitingObservational study
Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
Active, not recruitingObservational study
EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
Not yet recruiting
Oral Immunotherapy for Children With Egg Allergy
Egg Allergy, Egg Hypersensitivity
RecruitingPhase 2
Efficacy of Tezepelumab in Peanut Oral Immunotherapy
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.

Jose Saavedra, MD study director

Nestle Nutrition

Anna Nowak-Wegrzyn, MD principal investigator

Mount Sinai Department of Pediatrics

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 13 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 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

Hypoallergenicity (time frame: 14 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01278446.

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 4 Nov 2013.