None listed
Conditions
Brief summary
Peanut allergy affects up to 3% Australian children and peanut oral immunotherapy (POIT) is the most studied method for peanut desensitization. While results from POIT are generally promising, it is worthy to note that desensitization actually accounts for only the first year of treatment, after which regular maintenance of peanut ingestion demands much longer-term patience and perseverance. This is of great importance because many children dislike the taste of peanut, and it is timely to shift focus from initial safety to ongoing adherence in POIT. A major design-limitation of all currently published OIT studies is that they do not incorporate a well-structured protocol for maintenance therapy post-desensitization. This may contribute to non-adherence. A well-designed and high-quality post-desensitization RCT is therefore needed to make best use of the time and expense already put into OIT while maintaining the long-term benefit of desensitization in the years that follow. Successful desensitization can reduce psycho-social morbidity by offering the child protection from accidental ingestion of at least the same amount of desensitization-dose peanut. However, there no studies have been done to compare Quality of Life between adherent and non-adherent subjects post-desensitization. The fact that many desensitized children have opted to drop-out from treatment rather than maintaining ingestion is concerning, and may indicate that the time immediately after desensitization is an inflection point for Quality of Life changes. We think this study will reveal vital data in the understanding of causes and consequences of longer-term poor adherence after initially successful desensitization.
Interventions
In the previous HYPES study (see ACTRN12617000803392), children aged 6-18 with a clear positive history of peanut allergy and a SPT equal or greater than 8 mm, or psIgE equal or greater than 15 kU/L were treated with a 3-step desensitisation protocol as described in the clinical trial registration. To date, 56 subjects have completed the oral immunotherapy protocol, and all have passed the exit oral food challenge test (witnessed ingestion of 12 roasted peanuts or 3000 mg of peanut protein) afte
In the previous HYPES study (see ACTRN12617000803392), children aged 6-18 with a clear positive history of peanut allergy and a SPT equal or greater than 8 mm, or psIgE equal or greater than 15 kU/L were treated with a 3-step desensitisation protocol as described in the clinical trial registration. To date, 56 subjects have completed the oral immunotherapy protocol, and all have passed the exit oral food challenge test (witnessed ingestion of 12 roasted peanuts or 3000 mg of peanut protein) after a minimum of 12 months treatment. Following successful desensitisation, subjects were invited to participate in this follow-up study, in which they would be randomised into 2 groups for ongoing ingestion of roasted peanuts as maintenance. One group would be ingesting at least 2 roasted peanuts daily while the second group would be ingesting at least 14 peanuts all on one day once a week. We anticipate that some children might dislike the taste of peanuts while others might actually like to eat more or to try some other peanut products, so we have stratified the participants into “like” and “dislike” before randomizing each group. Children who liked peanuts would be allowed to consume ad libitum additional peanuts or peanut protein in other foods such as peanut butter/paste. Participants will be followed up for 12 months with 3 interviews: at base-line, mid-term (6 months) and exit (12 months), during which they would have skin prick tests, blood taken for psIgE, psIgG4, or any other relevant parameters, and a set of 7 psychological questionnaires evaluating stress, anxiety, depression, burden and quality of life, in both children and their parents. For those subjects randomised to ingest peanuts once a week, a special schedule of 3 months was designed to allow gradually transition from daily ingestion of 12 roasted peanuts to once weekly ingestion of 14 roasted peanuts, as follows: 1. Immediately after enrolment, subjects in Group B will increase their daily ingestion of peanuts from 12 per day to 14 per day over a 2 week period. They will then enter a transition phase, taking approximately 3 months to achieve: 2. Ingest peanuts every second day: on Day 1, 3, 5. 3. Ingest every third day: on Day 8, 11, 14. 4. Ingest every fourth day, on Day 18, 22, 26. 5. Ingest every fifth day, on Day 31, 36, 41. 6. Ingest every 6th day, on Day 47, 53, 59. 7. From Day 66 onwards: ingest once a week for the remaining treatment period of 12 months. 8. Patients are assessed at 3 months to see if the transition is successful. For those randomised to ingest peanuts daily, they would simply reduce their peanut intake from 12 peanuts daily to 2 peanuts daily. At the end of 12 months, all subjects will have a witnessed oral food challenge to confirm that they have successfully maintained their desensitised status. Subjects who consent to the study but refuse randomisation will be invited to answer the questionnaires at baseline and 12 months after desensitisation. Some of them might still be ingesting peanuts regularly, at their own choice but probably less disciplined than subjects in the formal randomised trial, or might have given up ingesting peanuts regularly altogether. We believe the psychological data from this sub-group of subjects could be very valuable, when compared with the more disciplined per-protocol participants. The following are the list of 7 questionnaires: Children: o Quality of life Peanut allergy PedQL o Revised Children’s Anxiety and Depression Scale (RCADS) o Perceived Stress Scale for Children (PSSC) Parents: o Food Quality of Life Parent Form o Food Allergy Quality of Life Parental Burden Scale o Depression, Anxiety and Stress Scale (DASS) o Perceived Stress Scale (PSS)
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
7 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Children and the parents of children who have (1) completed the HYPES study, (2) passed the exit oral food challenge of the HYPES study,
Exclusion criteria
Children and parents of children who had withdrawn or did not complete HYPES study (and passing the exit oral food challenge) - excluded because they were not successfully desensitized.
Outcome results
None listed