Environmental Peanut & tree nut elimination to enhance Oral immunotherapy in Children (EPOC): a randomized controlled trial

JRCT ID: jRCT1041230036

Registered date:12/06/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: IgE-mediated food allergy (peanut, tree- nut)
• Date of first enrollment: 12/06/2023
• Target sample size: 40
• Study type: Interventional

Intervention(s)

The environmental elimination group, as an intervention group, are instructed the removal of culprit foods from the household and the grandparents' house visited once a week or more until the end of the OFC two years later. The instruction includes thoroughly avoiding ingestion at home even for once a year. Furthermore, house cleaning, including wiping with water, is performed in the home with the highest visit frequency with intervention.
The continuous ingestion group is a non-intervention group that does not particularly restrict the ingestion of causative foods by family members.

Outcome(s)

• Primary Outcome: The single highest tolerated dose in the peanut/tree-nut OFC 24 months after the start of the trial (4-SU, four weeks sustained unresponsiveness)

Secondary Outcome

1. The intergroup difference in the rate of change in single highest tolerated dose in the peanut/tree-nut OFC between before the start of the trial and 24 months after the start of the trial.
2. The intergroup difference in the proportion (efficacy rate) of those whose single highest tolerated dose in the peanut/tree nut OFC improved to more than 30 times the baseline before the start of the trial and 24 months after the start of the trial.
3. The intragroup differences in the before-and-after single highest tolerated dose in the peanut/tree nut OFC before the start of the trial and 24 months after the start of the trial.
4. The intragroup and intergroup differences in the rate of change of specific IgE and specific IgG4 levels, as well as the mean wheal size of skin prick tests (SPT) to the culprit foods, before the start of the trial and 12 and 24 months after the start of the trial.
5. Regarding the environmental antigen levels:
5-a. The correlation between the rate of change in environmental antigen levels and the single highest tolerated dose in the peanut/tree nut oral food challenge before the start of the trial and 24 months after the start of the trial.
5-b. The correlation between the mean environmental antigen levels during the trial period and the rate of change of specific IgE levels, IgG4 levels, and SPT mean wheal size before the start of the trial and 12 and 24 months after the start of the trial.
5-c. The intragroup and intergroup differences in the environmental antigen levels at the start of the study.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 6age old
• Gender: Both

Include criteria

1. Pre-school children (under 6 years of age).
2. Those who avoid peanuts or tree nuts before starting oral immunotherapy.
3. Those who have had a positive result in an oral food challenge (OFC) for peanuts or tree nuts according to the PRACTALL criteria, with an amount of 0.1g to less than 3g.
4. Those who have had a positive result in food-specific IgE or SPT within the past 12 months.
5. Those whose legal guardians have provided written consent in this study.

Exclude criteria

1. Not consuming the study food in either the cohabiting family or grandparents of the study subject. at the time of obtaining consent.
2. Poor control of atopic dermatitis or bronchial asthma.
3. Chronic urticaria.
4. Those judged ineligible by the responsible physician or participating physician at the study site due to severe illnesses or other reasons.

Related Information

• Primary Sponsor: Natsume Osamu
• Secondary Sponsor: Hayano Satoshi
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research