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| ID | Type | Description | Link |
|---|---|---|---|
| 18/LO/1070 | Other Identifier | NHS Human Research Authority |
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| Name | Class |
|---|---|
| JP Moulton Charitable Foundation | OTHER |
| Sociedad Española de Alergología e Inmunología | UNKNOWN |
| Sociedad Española de Inmunología Clínica, Alergología y Asma Pediátrica | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLIT followed by Conventional OIT | Experimental | Participants will receive up to 7 months of SLIT followed by 6 months conventional OIT to cow's milk |
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| Conventional OIT | Active Comparator | Participants will receive up to 7 months of low dose OIT, followed by 6 months conventional OIT to cow's milk |
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| Delayed start OIT | Placebo Comparator | Participants will receive up to 7 months placebo, followed by 6 months conventional OIT to cow's milk |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLIT to cow's milk | Other | Sublingual immunotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events in participants | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Incidence of adverse events experienced (including rate of withdrawals, and anaphylaxis/adrenaline use during updosing) | 1 year |
| Eliciting dose(mg cow's milk protein) at DBPCFC after each phase of immunotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niño Jesús Hospital | Madrid | Spain | ||||
| Imperial College London / Imperial College Healthcare NHS Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34874567 | Derived | Turner PJ, Duca B, Chastell SA, Alvarez O, Bazire R, Vazquez-Ortiz M, Rodriguez Del Rio P. IgE-sensitization predicts threshold but not anaphylaxis during oral food challenges to cow's milk. Allergy. 2022 Apr;77(4):1291-1293. doi: 10.1111/all.15195. Epub 2021 Dec 14. No abstract available. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 24, 2023 | |
| Reset | Jan 25, 2024 | |
| Release | Mar 26, 2024 | |
| Reset | Aug 22, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2018 | Jan 14, 2023 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 24, 2023 | Jan 25, 2024 | |||
| Mar 26, 2024 |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Low dose OIT |
| Other |
Oral Immunotherapy (low dose) |
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| Conventional OIT to cow's milk | Other | Oral Immunotherapy |
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Efficacy defined at Double-blind, placebo-controlled food challenge (DBPCFC) as the proportion of study participants experiencing:
| 1 year |
| Change in Health-related quality of life (HRQL) from baseline - assessed using FAQLQ - after each phase of immunotherapy | 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) | 15 months |
| Change in Health-related quality of life (HRQL) from baseline - assessed using FAIM - after each phase of immunotherapy | 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) | 15 months |
| Change in Health-related quality of life (HRQL) from baseline - assessed using Change in EQ-5D from baseline - after each phase of immunotherapy | 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. | 15 months |
| Change in self-efficacy after each phase of immunotherapy | Change in self-efficacy at 6, 12 and 15 months from baseline, as assessed in study participants and their parent/carer using validated questionnaire. | 15 months |
| Immunological outcomes | Change in skin prick test wheal (mm), end-point titration skin prick test, allergen-specific IgE (KuA/l) between baseline and post immunotherapy | 12 months |
| Immunological outcome: skin prick test | Change in skin prick test wheal (mm) and end-point titration skin prick test between baseline and post immunotherapy | 12 months |
| Immunological outcomes: Allergen-specific IgE | Change in allergen-specific IgE (KuA/l) between baseline and post immunotherapy | 12 months |
| Peptide microarray | Trend in CM-peptide binding during OIT | 12 months |
| London |
| United Kingdom |
| Aug 22, 2024 |