Pilot study for a new oral immunotherapy for peanut allergy

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000919617
• Date of registration: 27/08/2014
• Prospective Registration: No
• Primary sponsor: Dr Billy Tao
• Public title: Pilot study for a new oral immunotherapy for peanut allergy
• Scientific title: A pilot study to test the safety and effectiveness of treatment with boiled peanuts to desensitise children with proven peanut allergy.
• Date of first enrolment: 20/05/2014
• Target sample size: 15
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000919617.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Billy Tao

• Name: Dr Billy Tao

Key inclusion & exclusion criteria

Inclusion criteria: Patients who are proven to be allergic to peanut by a positive open food challenge test immediately prior to enrolment into the study.
Exclusion criteria: 1. Serious medical co-morbidities.
2. Initial allergic reaction to peanut was life threatening.
3. Parents unable to supervise treatment or unwilling to sign informed consent.

Age minimum: 6 Years
Age maximum: 16 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Peanut allergy;
Peanut allergy

Inflammatory and Immune System - Allergies

Intervention(s)

Following confirmation of peanut allergy by a positive open food challenge test, patients aged 6 - 16 will be treated with increasing dosage of boiled peanuts starting with 1/4 of a boiled peanut per day for week 1; 1/4 of a boiled peanut twice a day for week 2 and 1/4 of a boiled peanut 3 times per day for week 3. For subsequent weeks, doses will be increased weekly up to target dose of 10 boiled peanuts in 3 divided doses per day at week 18. This dosage will be maintained for 3.5 months and then patients will return for their first dose of raw peanut, which will be 1/4 of a raw peanut and will be escalated using the same regime as for boiled peanuts until the patients can ingest 10 raw peanuts per day at 18 weeks from the first dose of raw peanut. The dosage will be gradually increased to 10 raw peanuts per day when this dosage will be maintained indefinitely. Treatment compliance and adverse events will be monitored by use of a diary.

Primary Outcome(s)

Proportion of participants that are able to ingest 10 or more raw/roasted peanuts per day on completion of Phase 2 treatment without any ongoing adverse effects. Examples of adverse effects are (in ascending order of severity): skin itchiness, urticaria and angioedema, allergic rhinitis or conjunctivitis, gastrointestinal symptoms such as abdominal pains, vomiting or diarrhoea, respiratory symptoms such as cough, wheeze, or breathing problems, fainting and anaphylaxis, based on clinical history and physical examination.
[12.5 months]

Incidence of adverse events more serious than cutaneous manifestations as a consequence of immunotherapy. Examples of such adverse events are: allergic rhinitis or conjunctivitis, gastrointestinal symptoms such as abdominal pains, vomiting or diarrhoea, respiratory symptoms such as cough, wheeze, or breathing problems, fainting and anaphylaxis, based on clinical history and physical examination[12.5 months]

Secondary Outcome(s)

Proportion of participants that are able to ingest 10 or more boiled peanuts per day on completion of Phase 1 treatment without any ongoing adverse effects. Examples of adverse effects are (in ascending order of severity): skin itchiness, urticaria and angioedema, allergic rhinitis or conjunctivitis, gastrointestinal symptoms such as abdominal pains, vomiting or diarrhoea, respiratory symptoms such as cough, wheeze, or breathing problems, fainting and anaphylaxis, based on clinical history and physical examination.[8 months]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Channel 7 Children's Research Foundation

Secondary Sponsor(s)

Flinders University

Ethics review

Status: Approved
Approval date:
Contact:

Southern Adelaide Clinical Human Research Ethics Committee