Peanut allergy trial
Does your child have a peanut allergy? The Children’s Hospital at Westmead is conducting a peanut allergy trial.
Principal Investigator: Prof Dianne Campbell
Project manager: Dr Michelle Barnes
The risk of accidental peanut contact or contamination for any child with a peanut allergy can be life threatening, but researchers are beginning to look at the problem of reducing acute allergy responses in new ways.
This trial, formally titled Oral peanut immunotherapy with a modified dietary starch adjuvant for treatment of peanut allergy, or OPIA for short, focuses on using small dose peanut challenges along with a dietary fibre supplement to train the body to become tolerant to peanut.
The dietary supplement of high-amylase maize starch with a short chain fatty acid called butyrate. Developed by the CSIRO, it is easily mixed into a range of foods, such as flavoured milk, juice, custard, or pasta sauce.
The duration of the study for most participants will be measured over one year.
Interested? Or know someone who might fit the criteria?
Please get in touch. Email Dr Michelle Barnes.
Recruitment for the trial closes in March 2020.
Find out more:
- If you are 10-14 years old, this information sheet is for you.
- If you are 14-16 years old, this information sheet is for you.
- If you are a parent, this information sheet is for you.
There are three groups in the study and once entered into the study each participant is randomised (by a computer) to receive one of three different treatments.
Two groups will receive oral peanut immunotherapy, which means they'll receive very small amounts of peanut. Doses are increased every two weeks if no adverse effects are observed at a hospital visit. Half of these participants will receive the active dietary supplement and the other participants will receive a placebo supplement.
The third and smaller group will be randomised to stay on standard care which is to avoid peanut for the first 12 months of the study. At the end of that 12 months of the study, children in the standard care control group will be offered the active peanut immunotherapy with supplement.
The study is a double-blind study, which means that neither the researchers nor the participants know which group they have been assigned to.
Because of the risk of severe allergic reaction, the trial will take place at the Hospital under careful observation by doctors and clinicians.
There are several screening processes to go through if you would like to be involved. These are designed so that we can find the most appropriate participants while maintaining strict adherence to the research criteria.
Children need to:
- be aged 10-16 years
- have a diagnosis of peanut allergy with a positive skin prick test to a commercially available peanut extract (wheal at least 3mm larger than the negative control)
- have confirmation of clinical reactivity to roasted peanut in a double blind, placebo-controlled food challenge
- be tolerant of soy as the challenge is given in a soy-based food
- have parental, or legal guardian consent, and
- the child must also agree to participate in the study.
Participation in extended trials can become onerous: participants need to come into the Hospital at least every two weeks, be available over an 12 month period, and be in a position to manage set backs such as delays if there’s a reaction, or if you fall ill.
Unfortunately, not everyone will be eligible. Some medical conditions can jeopardise a child’s health and medications may interfere with research results.
This project has been approved by Sydney Children’s Hospitals Network Human Research Ethics Committee.
If you have any concerns about the conduct of this study, please contact the Ethics Committee Executive Officer on 02 9845 3066 and quote approval number HREC/16/SCHN/372.