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NCT Number: NCT02216175

Improving the Safety of Oral Immunotherapy for Cow's Milk Allergy

Allergy to cow's milk is the most common food allergy affecting children. There is currently no accepted routine clinical therapy to cure milk allergy. Recently studies have attempted to induce desensitisation using small daily doses of cow's milk, predominantly by the oral route (oral immunotherapy, OIT). Although this therapy works for some people, its effects are not generally long lasting and it is associated with significant side effects during protocol, including potentially life-threatening allergic reactions.

Pilot data suggests that sublingual immunotherapy (SLIT, where allergen is held under the tongue, rather than swallowed) can also induce a degree of desensitisation, but with fewer adverse events. However, the degree of desensitisation induced appears to be lower than that with oral immunotherapy.

The investigators wish to determine whether a sublingual pretreatment phase can improve the safety of conventional OIT in cow's milk allergy.

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Key information

Conditions

Food Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Niño Jesús Hospital, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Allergic to 1.44g CM protein (approx. 40ml fresh milk) or less, at DBPCFC prior to randomisation
  • Informed consent of parent/legal guardian, patient assent where possible

Exclusion criteria

  • Required previous admission to an intensive care unit for management of an allergic reaction.
  • Significant symptoms of non---IgE---mediated CM allergy within the previous 12 months.
  • Children with a past history of CM allergy currently consuming CM-containing products other than extensively--heated milk in baked foods (e.g. biscuits, cakes).
  • Poorly controlled asthma within the previous 3 months (as defined by clinician judgement with reference to the ICON consensus), or asthma requiring treatment with >5 days oral corticosteroids within the previous 3 months.
  • Moderate---severe eczema, defined as requiring more than once daily application of 1% hydrocortisone as maintenance treatment despite appropriate use of emollients (eczema is not otherwise an exclusion criteria)
  • Clinically significant chronic illness (other than asthma, rhinitis or eczema)
  • History of symptoms of eosinophilic oesophagitis, irrespective of cause
  • Undergoing specific immunotherapy to another allergen and within the first year of treatment.
  • Receiving anti--IgE therapy, oral immunosuppressants, beta---blocker or ACE inhibitor.
  • Pregnancy
  • Unwilling or unable to fulfil study requirements

Treatment and study plan

SLIT to cow's milk

Other

Sublingual immunotherapy

Low dose OIT

Other

Oral Immunotherapy (low dose)

Conventional OIT to cow's milk

Other

Oral Immunotherapy

Primary outcomes

  1. Adverse events in participants

    Time frame: 1 year

    Proportion of participants experiencing adverse events (excluding mild, non-transient symptoms) conventional OIT to cow's milk in phase 2, in those who have received SLIT pretreatment compared to placebo.

Secondary outcomes

  1. Incidence of adverse events

    Time frame: 1 year

    Incidence of adverse events experienced (including rate of withdrawals, and anaphylaxis/adrenaline use during updosing)

  2. Eliciting dose(mg cow's milk protein) at DBPCFC after each phase of immunotherapy

    Time frame: 1 year

    Efficacy defined at Double-blind, placebo-controlled food challenge (DBPCFC) as the proportion of study participants experiencing:

    • No symptoms (or only mild transient symptoms) to 8 grams CM protein (approx. 250mls fresh milk) ("Complete desensitisation")
    • No symptoms (or only mild transient symptoms) to at least 1.4 grams CM protein (approx. 45mls fresh milk) ("Partial desensitisation")
    • At least a 10--fold increase in eliciting dose (defined as the lowest dose which elicits objective symptoms or signs at challenge). …at 6 and 12 months in the different treatment groups

  3. Change in Health-related quality of life (HRQL) from baseline - assessed using FAQLQ - after each phase of immunotherapy

    Time frame: 15 months

    Change in HRQL measures at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using the following validated questionnaire:

    • Food Allergy Quality of Life Questionnaires (FAQLQ)

  4. Change in Health-related quality of life (HRQL) from baseline - assessed using FAIM - after each phase of immunotherapy

    Time frame: 15 months

    Change in HRQL measures at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using the following validated questionnaire:

    • Food Allergy Independent Measure (FAIM)

  5. Change in Health-related quality of life (HRQL) from baseline - assessed using Change in EQ-5D from baseline - after each phase of immunotherapy

    Time frame: 15 months

    Change in HRQL measures at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using the following validated questionnaire:

    • EQ-5D - a standardized instrument for use as a measure of health outcome.

  6. Change in self-efficacy after each phase of immunotherapy

    Time frame: 15 months

    Change in self-efficacy at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using validated questionnaire.

  7. Immunological outcomes

    Time frame: 12 months

    Change in skin prick test wheal (mm), end-point titration skin prick test, allergen-specific IgE (KuA/l) between baseline and post immunotherapy

  8. Immunological outcome: skin prick test

    Time frame: 12 months

    Change in skin prick test wheal (mm) and end-point titration skin prick test between baseline and post immunotherapy

  9. Immunological outcomes: Allergen-specific IgE

    Time frame: 12 months

    Change in allergen-specific IgE (KuA/l) between baseline and post immunotherapy

  10. Peptide microarray

    Time frame: 12 months

    Trend in CM-peptide binding during OIT

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • JP Moulton Charitable Foundation
  • Sociedad Española de Alergología e Inmunología
  • Sociedad Española de Inmunología Clínica, Alergología y Asma Pediátrica

Registry information

Official study title

Phase 2/3 Clinical Trial to Assess the Effect of a Sublingual Treatment Phase Prior to Oral Immunotherapy in Children With Cow's Milk Allergy

Acronym: SOCMA

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Aug 13, 2014
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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