Food HypersensitivityNCT01569776
Elemental Formula Hypoallergenicity
A study testing Amino Acid formula and Commercially available Amino Acid Formula in people with Food Hypersensitivity, run by Société des Produits Nestlé (SPN) at 9 sites in United States.
Trial summary
The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA)… 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?
- Amino Acid formula and Commercially available Amino Acid Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2012to Apr 2013
- 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)
- 2 months to ≤12 years of age at enrollment
- Documented CMA within 6 months prior to enrollment
- Otherwise healthy
- Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
- Expected daily intake of at least 8 oz (240ml) 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 okay)
- Immunodeficiency
- Anti-histamine use in 7 days prior to the first food challenge (eyedrops are permitted)
Show all 13Show fewer
- Oral steroid use within 14 days prior to enrollment (intranasal and topical corticosteroid use are permitted)
- Unstable asthma
- Severe uncontrolled eczema
- Severe anaphylactic reaction to milk within the last 2 years
- Severe anaphylactic reaction to breastmilk within the last 2 years
- 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
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Georgia Pollens Clinical Research Centers Inc.
Albany, Georgia, 31707
TTS Research
Boerne, Texas, 78006
Deaconess Clinic, Inc.
Evansville, Indiana, 47713
Allergy & Asthma Physicians
Hinsdale, Illinois, 60521
Pediatric Care Medical Group, Inc.
Huntington Beach, California, 92647
Mount Sinai Medical Center
New York, New York, 10029
ENT & Allergy Associates
Newburgh, New York, 12550
Clinical Research Partners
Richmond, Virginia, 25233
Allergy & Asthma Medical Group and Research Center, A P.C.
San Diego, California, 92123
About this study
Official title: Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula
The primary objective of this clinical trial is to determine whether a new amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.
- Conditions
- Food Hypersensitivity
- Being tested
- Amino Acid formula, Commercially available Amino Acid Formula
- Keywords
- Cow 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.
Amino Acid formulaOther
Amino Acid baby formula
Commercially available Amino Acid FormulaOther
Hypoallergenic Baby formula
| Study group | Role | What they receive |
|---|---|---|
| New Amino Acid formula | Experimental | Not described Receives: Other: Amino Acid formula |
| Control formula | Active comparator | Commercially available Amino Acid infant formula Receives: Other: Commercially available Amino Acid Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of allergic reactions
occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)
Measured: 14 days
Secondary outcomes (1)
Digestive Tolerance
gastrointestinal tolerance and formula intake recorded during the open challenge phase.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Enrolment
- 37 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, Mount Sinai Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569776
- Sponsor's protocol ID
- 09.55.PED
- Status last verified
- Jun 2013
- First submitted
- 30 Mar 2012
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PubMed 33006765
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hypoallergenicity of an Amino Acid-Based Infant Formula
- ClinicalTrials.gov ID
- NCT01569776
- Acronym / sponsor ID
- 09.55.PED
- Conditions
- Food Hypersensitivity
- Keywords
- Cow milk allergy, CMA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Apr 2012 (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 amino acid-based formula is hypoallergenic as defined by the American Academy of Pediatrics (2000), demonstrating that the test formula does not provoke allergenic activity in 90% of infants or children with confirmed cow's milk allergy (CMA) with 95% confidence as compared to a commercially available hypoallergenic formula.
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 |
|---|---|---|
| New Amino Acid formula | Experimental | Other: Amino Acid formula |
| Control formula | Active comparator | Other: Commercially available Amino Acid FormulaCommercially available Amino Acid infant formula |
Who may qualify
- Ages
- 2 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Born at term (>36 weeks gestation)
- 2 months to ≤12 years of age at enrollment
- Documented CMA within 6 months prior to enrollment
- Otherwise healthy
- Asthma, atopic dermatitis and/or rhinitis must be well-controlled, if applicable
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 okay)
- 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 |
|---|---|---|
| Amino Acid formulaAmino Acid baby formula | Other | New Amino Acid formula |
| Commercially available Amino Acid FormulaHypoallergenic Baby formula | Other | Control formula |
Primary outcome
occurrence of allergic reactions
Time frame: 14 days
occurrence of allergic reactions to double-blind placebo controlled food challenge (DBPCFC)
1 secondary outcome
Digestive Tolerance
Time frame: one 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 26 Jun 2013.
- Derived from this study: PubMed 33006765Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
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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
Mount Sinai Department of Pediatrics
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acid formula and Commercially available Amino Acid Formula in people with Food Hypersensitivity, run by Société des Produits Nestlé (SPN) at 9 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 7 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 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
occurrence of allergic reactions (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 NCT01569776, which also lists 1 linked publication.
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 26 Jun 2013.