Milk Oral Immunotherapy in Children to Treat Food Allergy

NCT01162473 | Completed Early Phase 1 Results

• 1 other identifier: 09-007320
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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%. 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.

Conditions

Milk Hypersensitivity

Keywords

Food hypersensitivity; Milk hypersensitivity; Milk allergy; Food allergy

Outcome Measures

Primary Outcomes (1)

• 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".

  1 year

Study Arms (2)

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.

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.

Dietary Supplement: Milk Oral Immunotherapy; Drug: Milk Protein Powder; Other: Food Challenge

Interventions

Milk Oral Immunotherapy DIETARY_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.

Delayed Sensitivity; Immediate Sensitivity

Milk Protein Powder DRUG

Milk protein powder will be administered in incremental doses during the desensitization protocol.

Delayed Sensitivity; Immediate Sensitivity

Food Challenge OTHER

Delayed Sensitivity; Immediate Sensitivity

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

• 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.

  PMID: 16597075 BACKGROUND

• Skripak 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.

  PMID: 18951617 BACKGROUND

• Longo 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.

  PMID: 18158176 BACKGROUND

• Meglio 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.

  PMID: 15291907 BACKGROUND

• Zapatero 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.

  PMID: 18973104 BACKGROUND

MeSH Terms

Conditions

Milk Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

The small sample size constrains the statistical significance of this study. While useful in indicating potential trends, the results of this pilot study should be cautiously interpreted.

Results Point of Contact

• Title: Rushani W. Saltzman MD
• Organization: The Children's Hospital of Philadelphia

allergyandimmunology@email.chop.edu

215-590-2549

Study Officials

• Jonathan M. Spergel, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Antonella Cianferoni, MD, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 14, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 13, 2015
• Results First Posted: May 13, 2015

Record last verified: 2015-05

Locations

US (1)