Milk HypersensitivityEarly Phase 1NCT01162473
Milk Oral Immunotherapy in Children to Treat Food Allergy
A Early Phase 1 study testing Milk Oral Immunotherapy, Milk Protein Powder and Food Challenge in people with Milk Hypersensitivity, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Background and Rationale For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Specifically, among young children, cow's milk allergy is the most common food allergy, occurring in as many as 2-3%. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Milk Hypersensitivity
- What is being tested?
- Milk Oral Immunotherapy, Milk Protein Powder and Food Challenge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2013
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must be age six to 17 years and have a history of cow's milk allergy. Subjects shall maintain strict avoidance of consumption of all cow's milk protein containing foods.
- Subjects will have a history (within the past six months) of a positive skin prick test to milk extract or an immunocap IgE level greater than 0.35 kilounits per liter (kU/L), and a positive allergic reaction history to milk within the past 12 months.
- Subjects must be in good health, as determined by medical history and physical examination performed by a study physician.
- Females of childbearing potential must be using an effective method of contraception, including abstinence, and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
- Informed consent of parent or legal guardian is required.
Who cannot join
- Ability to tolerate eight ounces of cow's milk or eight grams of milk protein powder
- Pregnancy
- A history of soy allergy
- A history of food protein induced enterocolitis syndrome to milk
- A history of anaphylaxis requiring hospitalization
- A history of intubation related to asthma and/or a history of an intensive care unit admission for asthma management
Show all 16Show fewer
- A current diagnosis of severe persistent asthma [forced expiratory volume in 1 second (FEV1) < 60% of predicted, as defined by National Heart, Lung, and Blood Institute (NHLBI) guidelines, despite current therapy
- A current diagnosis of severe atopic dermatitis
- A serious chronic medical condition, including neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease
- Use of oral or injection steroids within one month of protocol initial visit
- An acute illness within one week prior to the first dose of oral immunotherapy
- Use of antihistamines within seven days prior to double blind placebo controlled food challenge (DBPCFC)
- Use of chronic immunomodulatory therapy
- Participation in another experimental therapy study
- Participation in a study for the treatment of food allergy in the past 12 months
- Inability to discontinue antihistamines for skin testing and food challenges
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Study of the Efficacy of Milk Oral Immunotherapy in Children
Background and Rationale
For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Specifically, among young children, cow's milk allergy is the most common food allergy, occurring in as many as 2-3%. Given the prevalence of milk and the difficulty to avoid it in the diet, the investigators aim to investigate the safety and efficacy of oral immunotherapy for cow's milk allergy.
Read more
Main Objective
The primary objective is to study the efficacy of milk oral immunotherapy.
Target Population
Children aged six to 17 years with a history of cow's milk allergy will be recruited from The Children's Hospital of Philadelphia Allergy clinical offices for the investigators study.
Read the detailed description
Primary Study Interventions
Prior to and after the desensitization, we will conduct double-blind placebo controlled food challenges to cow's milk protein. During the desensitization phase, we will give increasing doses of cow's milk protein by mouth on a weekly basis, as tolerated. The desensitization protocol starts with dilutional doses of milk and build up to a goal of 8 ounces of cow's milk.
Main Study Outcome Measure
The percentage of children completing the desensitization protocol in each study group will be the primary outcome measure.
- Conditions
- Milk Hypersensitivity
- Being tested
- Milk Oral Immunotherapy, Milk Protein Powder, Food Challenge
- Keywords
- Food hypersensitivity, Milk hypersensitivity, Milk allergy, Food allergy
- Medical subject headings
- Milk Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk Oral ImmunotherapyDietary supplement
Subjects will participate in a desensitization protocol over the course of 13 weeks to reach a goal maintenance dose of 8 ounces of cow's milk. Once reaching maintenance, subjects will continue on this dose for 12 additional weeks.
Milk Protein PowderDrug
Milk protein powder will be administered in incremental doses during the desensitization protocol.
Food ChallengeOther
| Study group | Role | What they receive |
|---|---|---|
| Delayed Sensitivity | Active comparator | All subjects will undergo a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 16 and continue thru Week 50. Total active participation will last 51 weeks. Receives: Dietary Supplement: Milk Oral Immunotherapy; Drug: Milk Protein Powder; Other: Food Challenge |
| Immediate Sensitivity | Active comparator | All subjects will undergo a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 3 and continue thru Week 35. Total active participation will last 38 weeks. Receives: Dietary Supplement: Milk Oral Immunotherapy; Drug: Milk Protein Powder; Other: Food Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Completed Desensitization Protocol
Subjects who withdrew prior to completing the desensitization protocol and those who experienced anaphylaxis during the desensitization protocol (i.e., were unable to complete the protocol) were considered to be "treatment failures". Subjects who completed the desensitization protocol were considered to be "treatment successes".
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Milk HypersensitivityStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan M. Spergel, MD, PhD, Principal investigator, Children's Hospital of PhiladelphiaAntonella Cianferoni, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162473
- Sponsor's protocol ID
- 09-007320
- Status last verified
- May 2015
- First submitted
- 13 Jul 2010
- Last updated
- 13 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bollinger ME, Dahlquist LM, Mudd K, Sonntag C, Dillinger L, McKenna K. The impact of food allergy on the daily activities of children and their families. Ann Allergy Asthma Immunol. 2006 Mar;96(3):415-21. doi: 10.1016/S1081-1206(10)60908-8.
PubMed 16597075Skripak JM, Nash SD, Rowley H, Brereton NH, Oh S, Hamilton RG, Matsui EC, Burks AW, Wood RA. A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy. J Allergy Clin Immunol. 2008 Dec;122(6):1154-60. doi: 10.1016/j.jaci.2008.09.030. Epub 2008 Oct 25.
PubMed 18951617Longo G, Barbi E, Berti I, Meneghetti R, Pittalis A, Ronfani L, Ventura A. Specific oral tolerance induction in children with very severe cow's milk-induced reactions. J Allergy Clin Immunol. 2008 Feb;121(2):343-7. doi: 10.1016/j.jaci.2007.10.029. Epub 2007 Dec 26.
PubMed 18158176Meglio P, Bartone E, Plantamura M, Arabito E, Giampietro PG. A protocol for oral desensitization in children with IgE-mediated cow's milk allergy. Allergy. 2004 Sep;59(9):980-7. doi: 10.1111/j.1398-9995.2004.00542.x.
PubMed 15291907Zapatero L, Alonso E, Fuentes V, Martinez MI. Oral desensitization in children with cow's milk allergy. J Investig Allergol Clin Immunol. 2008;18(5):389-96.
PubMed 18973104
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy of Milk Oral Immunotherapy in Children
- ClinicalTrials.gov ID
- NCT01162473
- Acronym / sponsor ID
- 09-007320
- Conditions
- Milk Hypersensitivity
- Keywords
- Food hypersensitivity, Milk hypersensitivity, Milk allergy, Food allergy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Jul 2010 (estimated)
- Results
- Posted 13 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Rationale
For patients with Immunoglobulin E (IgE)-mediated food allergy, the current management includes identification of the causative food and avoidance. Specifically, among young children, cow's milk allergy is the most common food allergy, occurring in as many as 2-3%. Given the prevalence of milk and the difficulty to avoid it in the diet, the investigators aim to investigate the safety and efficacy of oral immunotherapy for cow's milk allergy.
Main Objective
The primary objective is to study the efficacy of milk oral immunotherapy.
Target Population
Children aged six to 17 years with a history of cow's milk allergy will be recruited from The Children's Hospital of Philadelphia Allergy clinical offices for the investigators study.
Detailed description
Primary Study Interventions
Prior to and after the desensitization, we will conduct double-blind placebo controlled food challenges to cow's milk protein. During the desensitization phase, we will give increasing doses of cow's milk protein by mouth on a weekly basis, as tolerated. The desensitization protocol starts with dilutional doses of milk and build up to a goal of 8 ounces of cow's milk.
Main Study Outcome Measure
The percentage of children completing the desensitization protocol in each study group will be the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Sensitivity | Active comparator | Dietary Supplement: Milk Oral Immunotherapy, Drug: Milk Protein Powder, Other: Food ChallengeAll subjects will undergo a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 16 and continue thru Week 50. Total active participation will last 51 weeks. |
| Immediate Sensitivity | Active comparator | Dietary Supplement: Milk Oral Immunotherapy, Drug: Milk Protein Powder, Other: Food ChallengeAll subjects will undergo a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder will begin build-up of desensitization during Week 3 and continue thru Week 35. Total active participation will last 38 weeks. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects must be age six to 17 years and have a history of cow's milk allergy. Subjects shall maintain strict avoidance of consumption of all cow's milk protein containing foods.
- Subjects will have a history (within the past six months) of a positive skin prick test to milk extract or an immunocap IgE level greater than 0.35 kilounits per liter (kU/L), and a positive allergic reaction history to milk within the past 12 months.
- Subjects must be in good health, as determined by medical history and physical examination performed by a study physician.
- Females of childbearing potential must be using an effective method of contraception, including abstinence, and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study.
- Informed consent of parent or legal guardian is required.
Key exclusion criteria (16 listed)
- Ability to tolerate eight ounces of cow's milk or eight grams of milk protein powder
- Pregnancy
- A history of soy allergy
- A history of food protein induced enterocolitis syndrome to milk
- A history of anaphylaxis requiring hospitalization
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 |
|---|---|---|
| Milk Oral ImmunotherapySubjects will participate in a desensitization protocol over the course of 13 weeks to reach a goal maintenance dose of 8 ounces of cow's milk. Once reaching maintenance, subjects will continue on this dose for 12 additional weeks. | Dietary supplement | Delayed Sensitivity, Immediate Sensitivity |
| Milk Protein PowderMilk protein powder will be administered in incremental doses during the desensitization protocol. | Drug | Delayed Sensitivity, Immediate Sensitivity |
| Food Challenge | Other | Delayed Sensitivity, Immediate Sensitivity |
Primary outcome
Number of Subjects Who Completed Desensitization Protocol
Time frame: 1 year
Subjects who withdrew prior to completing the desensitization protocol and those who experienced anaphylaxis during the desensitization protocol (i.e., were unable to complete the protocol) were considered to be "treatment failures". Subjects who completed the desensitization protocol were considered to be "treatment successes".
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16597075Bollinger ME, Dahlquist LM, Mudd K, Sonntag C, Dillinger L, McKenna K. The impact of food allergy on the daily activities of children and their families. Ann Allergy Asthma Immunol. 2006 Mar;96(3):415-21. doi: 10.1016/S1081-1206(10)60908-8.
- Background: PubMed 18951617Skripak JM, Nash SD, Rowley H, Brereton NH, Oh S, Hamilton RG, Matsui EC, Burks AW, Wood RA. A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy. J Allergy Clin Immunol. 2008 Dec;122(6):1154-60. doi: 10.1016/j.jaci.2008.09.030. Epub 2008 Oct 25.
- Background: PubMed 18158176Longo G, Barbi E, Berti I, Meneghetti R, Pittalis A, Ronfani L, Ventura A. Specific oral tolerance induction in children with very severe cow's milk-induced reactions. J Allergy Clin Immunol. 2008 Feb;121(2):343-7. doi: 10.1016/j.jaci.2007.10.029. Epub 2007 Dec 26.
- Background: PubMed 15291907Meglio P, Bartone E, Plantamura M, Arabito E, Giampietro PG. A protocol for oral desensitization in children with IgE-mediated cow's milk allergy. Allergy. 2004 Sep;59(9):980-7. doi: 10.1111/j.1398-9995.2004.00542.x.
- Background: PubMed 18973104Zapatero L, Alonso E, Fuentes V, Martinez MI. Oral desensitization in children with cow's milk allergy. J Investig Allergol Clin Immunol. 2008;18(5):389-96.
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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.
Jonathan M. Spergel, MD, PhD principal investigator
Children's Hospital of Philadelphia
Antonella Cianferoni, MD, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Milk Oral Immunotherapy, Milk Protein Powder and Food Challenge in people with Milk Hypersensitivity, run by Children's Hospital of Philadelphia 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 5 inclusion and 16 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 13 May 2015. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Who Completed Desensitization Protocol (time frame: 1 year). 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 NCT01162473, which also lists 5 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 13 May 2015.