Food AllergyNCT02397876
Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients
A study testing Partially Hydrolyzed Whey formula in people with Food Allergy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Cow's milk (CM) allergy is the most common food allergy in children, affecting 2-3% of infants. In formula-fed infants with CM allergy, extensively hydrolyzed or amino acid-based infant formulas are typically recommended. These formulas are expensive and not palatable. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Partially Hydrolyzed Whey formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 0.5-18 years old
- positive skin prick tests (SPT) or detectable serum milk specific IgE and a history of an allergic reaction to milk within 6 months before study screening; or milk-specific IgE level or SPT highly predictive for clinical reactivity (if ≤ 2 years old, sIgE >2 kU/L; if > 2 years old, a level >5 kU/L; SPT wheal diameter ≥ 3 mm)
- a clinical reaction during the cows milk oral food challenge
Who cannot join
- negative SPT and undetectable milk-specific sIgE
- unstable asthma, allergic rhinitis, or atopic dermatitis
- milk-induced eosinophilic gastroenteropathy
- recent reaction to partially hydrolyzed whey formula
- history of severe anaphylaxis with hypotension to cows milk
- participation in any interventional study for the treatment of food allergy in the 6 months prior to screening visit
Show all 12Show fewer
- inhalant allergent immunotherapy that has not yet reached maintenance dosing
- inability to discontinue antihistamines for skin testing, OFC
- any systemic therapy which in the judgment of the investigator could be immunomodulatory in the 12 months prior to visit 1 (xolair, rituximab, chronic steroids, etc)
- investigational drug use 90 days prior to visit 1 or intention to use during study period
- the presence of any medical condition that the investigator deems incompatible with participation in the trial.
- unable to understand and speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Cow's milk (CM) allergy is the most common food allergy in children, affecting 2-3% of infants. In formula-fed infants with CM allergy, extensively hydrolyzed or amino acid-based infant formulas are typically recommended. These formulas are expensive and not palatable. For older patients with CM allergy, the standard of care is avoidance of all CM products. The investigators cared for a CM allergic patient who was able to tolerate partially hydrolyzed whey formula (pHWF), which tastes better and is less expensive than extensively hydrolyzed or amino-acid based formulas. There are likely other subjects who could similarly tolerate pHWF. Furthermore, it is possible that taking pHWF could accelerate tolerance of CM. The investigators aim to identify characteristics of CM allergic subjects who can tolerate pHWF and assess the degree to which taking pHWF accelerates CM tolerance.
Read the detailed description
Specifically, subjects who have CM allergy will be enrolled. The investigators will perform an oral food challenge (OFC) to pHWF in each subject. Subjects who pass the challenge will be placed on pHWF for 2 years. Subjects who do not pass the challenge will receive routine care. The investigators will perform allergy skin testing, specific IgE measurement, other serologic assays, and longitudinal OFCs to profile subject characteristics in the two groups at baseline and over time.
- Conditions
- Food Allergy
- Being tested
- Partially Hydrolyzed Whey formula
- Keywords
- Food Allergy, Cows Milk Allergy
- 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.
Partially Hydrolyzed Whey formulaOther
Also called Gerber Good Start Formula
Patients who tolerate partially hydrolyzed whey formula will be continued on this formula for two years. Patients who do not tolerate the formula will be continued on their prior diet of cows milk avoidance.
| Study group | Role | What they receive |
|---|---|---|
| partially hydrolyzed whey formula | Experimental | The group of patients who pass an oral food challenge to partially hydrolyzed whey formula and will be continued on it through out the study Receives: Other: Partially Hydrolyzed Whey formula |
| No intervention | No intervention | Patients who do not pass an oral food challenge to partially hydrolyzed whey formula will continue on their prior diet of cows milk avoidance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of partially hydrolyzed whey formula tolerance
Prevalence of partially hydrolyzed whey formula tolerance in cow's milk allergic patients - Identify patients who are cow's milk allergic but can tolerate a partially hydrolyzed whey formula
Measured: Day 1
Secondary outcomes (1)
Time to resolution of cows milk allergy
Determine if ingestion of partially hydrolyzed whey formula accelerates the resolution of allergy to cow's milk.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Responsible party
- Sponsor
- Investigators
- Supinda Bunyavanich, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397876
- Sponsor's protocol ID
- GCO 14-2009
- Status last verified
- Dec 2016
- First submitted
- 19 Mar 2015
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wood RA, Sicherer SH, Vickery BP, Jones SM, Liu AH, Fleischer DM, Henning AK, Mayer L, Burks AW, Grishin A, Stablein D, Sampson HA. The natural history of milk allergy in an observational cohort. J Allergy Clin Immunol. 2013 Mar;131(3):805-12. doi: 10.1016/j.jaci.2012.10.060. Epub 2012 Dec 28.
PubMed 23273958Jin YT. [Surgical treatment of post-traumatic enophthalmos (report of 5 cases)]. Zhonghua Zheng Xing Shao Shang Wai Ke Za Zhi. 1987 Sep;3(3):184-6, 238. No abstract available. Chinese.
PubMed 3151608Reed RJ, Hairston MA, Palomeque FE. The histologic identity of adenoma sebaceum and solitary melanocytic angiofibroma. Dermatol Int. 1966 Jan-Mar;5(1):3-11. doi: 10.1111/j.1365-4362.1966.tb05174.x. No abstract available.
PubMed 4293047Lee TD, Gimenez G, Grishina G, Mishoe M, Sampson HA, Bunyavanich S. Profile of a milk-allergic patient who tolerated partially hydrolyzed whey formula. J Allergy Clin Immunol Pract. 2015 Jan-Feb;3(1):116-8. doi: 10.1016/j.jaip.2014.06.021. Epub 2014 Aug 29. No abstract available.
PubMed 25577632
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partially Hydrolyzed Whey Formula in Cow's Milk Allergic Patients
- ClinicalTrials.gov ID
- NCT02397876
- Acronym / sponsor ID
- GCO 14-2009
- Conditions
- Food Allergy
- Keywords
- Food Allergy, Cows Milk Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Société des Produits Nestlé (SPN)
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Mar 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.
Cow's milk (CM) allergy is the most common food allergy in children, affecting 2-3% of infants. In formula-fed infants with CM allergy, extensively hydrolyzed or amino acid-based infant formulas are typically recommended. These formulas are expensive and not palatable. For older patients with CM allergy, the standard of care is avoidance of all CM products. The investigators cared for a CM allergic patient who was able to tolerate partially hydrolyzed whey formula (pHWF), which tastes better and is less expensive than extensively hydrolyzed or amino-acid based formulas. There are likely other subjects who could similarly tolerate pHWF. Furthermore, it is possible that taking pHWF could accelerate tolerance of CM. The investigators aim to identify characteristics of CM allergic subjects who can tolerate pHWF and assess the degree to which taking pHWF accelerates CM tolerance.
Detailed description
Specifically, subjects who have CM allergy will be enrolled. The investigators will perform an oral food challenge (OFC) to pHWF in each subject. Subjects who pass the challenge will be placed on pHWF for 2 years. Subjects who do not pass the challenge will receive routine care. The investigators will perform allergy skin testing, specific IgE measurement, other serologic assays, and longitudinal OFCs to profile subject characteristics in the two groups at baseline and over time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| partially hydrolyzed whey formula | Experimental | Other: Partially Hydrolyzed Whey formulaThe group of patients who pass an oral food challenge to partially hydrolyzed whey formula and will be continued on it through out the study |
| No intervention | No intervention | –Patients who do not pass an oral food challenge to partially hydrolyzed whey formula will continue on their prior diet of cows milk avoidance. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 0.5-18 years old
- positive skin prick tests (SPT) or detectable serum milk specific IgE and a history of an allergic reaction to milk within 6 months before study screening; or milk-specific IgE level or SPT highly predictive for clinical reactivity (if ≤ 2 years old, sIgE >2 kU/L; if > 2 years old, a level >5 kU/L; SPT wheal diameter ≥ 3 mm)
- a clinical reaction during the cows milk oral food challenge
Key exclusion criteria (12 listed)
- negative SPT and undetectable milk-specific sIgE
- unstable asthma, allergic rhinitis, or atopic dermatitis
- milk-induced eosinophilic gastroenteropathy
- recent reaction to partially hydrolyzed whey formula
- history of severe anaphylaxis with hypotension to cows milk
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 |
|---|---|---|
| Partially Hydrolyzed Whey formulaAlso: Gerber Good Start FormulaPatients who tolerate partially hydrolyzed whey formula will be continued on this formula for two years. Patients who do not tolerate the formula will be continued on their prior diet of cows milk avoidance. | Other | partially hydrolyzed whey formula |
Primary outcome
Prevalence of partially hydrolyzed whey formula tolerance
Time frame: Day 1
Prevalence of partially hydrolyzed whey formula tolerance in cow's milk allergic patients - Identify patients who are cow's milk allergic but can tolerate a partially hydrolyzed whey formula
1 secondary outcome
Time to resolution of cows milk allergy
Time frame: up to 2 years
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 7 Dec 2016.
- Background: PubMed 23273958Wood RA, Sicherer SH, Vickery BP, Jones SM, Liu AH, Fleischer DM, Henning AK, Mayer L, Burks AW, Grishin A, Stablein D, Sampson HA. The natural history of milk allergy in an observational cohort. J Allergy Clin Immunol. 2013 Mar;131(3):805-12. doi: 10.1016/j.jaci.2012.10.060. Epub 2012 Dec 28.
- Background: PubMed 3151608Jin YT. [Surgical treatment of post-traumatic enophthalmos (report of 5 cases)]. Zhonghua Zheng Xing Shao Shang Wai Ke Za Zhi. 1987 Sep;3(3):184-6, 238. No abstract available. Chinese.
- Background: PubMed 4293047Reed RJ, Hairston MA, Palomeque FE. The histologic identity of adenoma sebaceum and solitary melanocytic angiofibroma. Dermatol Int. 1966 Jan-Mar;5(1):3-11. doi: 10.1111/j.1365-4362.1966.tb05174.x. No abstract available.
- Background: PubMed 25577632Lee TD, Gimenez G, Grishina G, Mishoe M, Sampson HA, Bunyavanich S. Profile of a milk-allergic patient who tolerated partially hydrolyzed whey formula. J Allergy Clin Immunol Pract. 2015 Jan-Feb;3(1):116-8. doi: 10.1016/j.jaip.2014.06.021. Epub 2014 Aug 29. No abstract available.
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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.
Supinda Bunyavanich, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partially Hydrolyzed Whey formula in people with Food Allergy, run by Icahn School of Medicine at Mount Sinai at 1 site 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 3 inclusion and 12 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 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Prevalence of partially hydrolyzed whey formula tolerance (time frame: Day 1). 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 NCT02397876, which also lists 4 linked publications.
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 7 Dec 2016.