NCT02216175

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Food Allergy

Interventions

Type	Name	Description
OTHER	SLIT to cow's milk	Sublingual immunotherapy
OTHER	Low dose OIT	Oral Immunotherapy (low dose)
OTHER	Conventional OIT to cow's milk	Oral Immunotherapy

Timeline

• Start date: 2018-07-19
• Primary completion: 2021-09-30
• Completion: 2022-01-19
• First posted: 2014-08-13
• Last updated: 2023-01-18

Locations

2 sites across 2 countries: Spain, United Kingdom