Walnut Intake for supression of high-level sensitization in Japan

JRCT ID: jRCTs031240341

Registered date:17/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Walnut sensitization
• Date of first enrollment: 17/09/2024
• Target sample size: 220
• Study type: Interventional

Intervention(s)

Group A will be fed walnut powder once a day, 3 days a week, from 6-8 months of age until 24 months of age
Group B will be fed walnut powder once a day, 3 days a week, from 12-14 months of age until 24 months of age

Outcome(s)

• Primary Outcome: Incidence of sensitization (>=0.35IU) to Jugr1-specific IgE by Immuno CAP at 24 months of age

Secondary Outcome

1. Incidence of sensitized (>=0.35IU ) Jugr1-specific IgE at 12 months of age
2. Incidence of Jugr1-specific IgE >=0.70IU at 12 and 24 months of age
3.Incidence of sensitized (>=0.35IU) walnut crude antigen-specific IgE at 12 and 24 months of age
4.Incidence of walnut crude antigen-specific IgE >=0.70IU at 12 and 24 months of age
5. total IgE and specific IgE levels during the study period (target antigen: walnut crude antigen, Jugr1)
6.Incidence of positive results in the oral load test equivalent to 4 g of walnuts at Visit 6 (if desired)
7. History of immediate-type walnut allergy at Visit 6 (medical history interview)
8. Presence of protein-induced gastroenteropathy due to walnuts at Visit 6 (medical history)
9.Serum TARC level during the study period 10.
10.Patient oriented eczema measure (POEM) score during the study period
11.EASI (Eczema Area and Severity Index) score during the study period
12. Caregiver burden related to the study intervention during the study intervention
13.Exhaled wheezing during the intervention period (history taking)
14. Allergic symptoms during the intervention period
Presence or absence of allergic rhinitis during the intervention period (history taking) 15.
15. Adherence to the intake of the test foods
16.Incidence of serious adverse events during the intervention period

Key inclusion & exclusion criteria

• Age minimum: >= 5month old
• Age maximum: <= 7month old
• Gender: Both

Include criteria

1. Infants between the ages of 5 and 7 months.
2. Infants who can be diagnosed, or can be judged to have been diagnosed, with atopic dermatitis at less than 6 months of age using the UK Working Party diagnostic criteria at the time of consent (including infants who have already started treatment and are in remission).
3. Infants who have been informed about the study, fully understand it, and have given written consent to participate in the study from their surrogate(s).

Exclude criteria

1. Infants born at less than 37 weeks of gestational age
2. Infants who have consumed walnuts or walnut products
3. Suspected or existing history of food protein-induced gastrointestinal disorders.
4. Infants with medical conditions that may interfere with the study (e.g., underlying medical condition requiring tube feeding, underlying medical condition that is likely to result in prolonged hospitalization during the study period for treatment or surgery, etc.)
5. Infants of surrogates who are unable to communicate adequately in Japanese.
6.Infants who are deemed ineligible by the Principal Investigator or Sub-Principal Investigato

Related Information

• Primary Sponsor: Yamamoto-Hanada Kiwako
• Source(s) of Monetary Support: National Center for Child Health and Development,Grant from National Center for Child Health and Development