Eczema, atopic dermatitis Eczema
Conditions
Interventions
Participants in the intervention group (23 children and 15 adults) will receive written and oral dietary advice from a dietitian about an individually tailored immune supportive diet (ISD) for 4 month
The ISD: 
a. is applicable for individuals =1 year of age, 
b. is based on a total diet approach rather than on single nutrients, 
c. is based on a healthy diet complying with national and international guidelines for macro- and micronutrients, 
d. has special focus on foods that enhance the innate and adaptive immune function through anti-inflammatory effects and their beneficial impact on the microbiome and gut permeability, 
e. is based on the association between diet and allergic disease. 
Criteria of the ISD: 
• contains an abundancy of fresh, whole or minimally processed foods (NOVA-classification 1–3) 
• preferably home cooked, locally produced, and seasonal food, 
• a high diversity of foods taken from all food groups, 
• plant-based foods (50-60% of protein), which comply with the sustainable, worldwide Planetary Health Diet  
and come close to the latest recommendations of the Health Council of the Netherlands to shift towards more plant-based proteins,
• foods rich in dietary fiber, 
• foods rich in flavonoids, e.g. herbs, spices, tea, fruits, vegetables, 
• fermented foods and foods naturally rich in beneficial food microbes, e.g. kimchi, sauerkraut or fresh and unheated foods, such as raw fruits and vegetables
 
• foods rich in ome
Sponsors
OLVG
Eligibility
Age
No minimum to 99 Years
Inclusion criteria
Inclusion criteria: =1year of age,Diagnosed moderate to severe AD, POEM score 8-24. A patient oriented clinical score was taken as feasible inclusion criterion which can be used at home Use of corticosteroids,Usual skin care, according to standard care. Able to speak and write Dutch or English or are able to use google translate properly as participants should be able to read food labels properly.
Exclusion criteria
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:Other skin diseases,Pregnancy,Multiple clinical relevant IgE-mediated food allergy,Avoidance of all dairy or gluten,Extensive eliminations due to Pollen Food Syndrome,Using systemic immune suppressants or biologicals,Antibiotics shorter than 4 weeks prior to the study or use of probiotics shorter than 4 weeks prior to the study,Individual participants will not start the ISD just before the time of the year in which the AD is usually worsening,Tape stripping will not be performed within 2 weeks after a build-up phase of corticosteroids, or if AD is only present at hands, feet and/or face (or scalp).Not willing to stop probiotic and nutrient supplements from 4 and 2 weeks subsequently prior to the start of the study (except medically prescribed or recommended for age such as vitamin D)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in in AD severity using Eczema Area and Severity Index (EASI) score, assessed by a blinded dermatologist. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical assessment: Immune status by production of cytokines (IL-1a, IL-1RA, TARC en NMF (natural moisturising factor) in the skin, using tape stripping at baseline and after 4 months Skin barrier by Trans Epidermal Water Loss (TEWL) at baseline and after 4 months Immune markers in saliva (sIgA, SLPI, CRP, IL-6, TNFa, IL-1ß, IL-10 en MMP-9), at baseline and after 4 months Nutritional status in saliva sample (e.g. iron, zinc, selenium, vitamin A,D, E) at baseline and after 4 months.Patient reported outcomes: Severity of AD by Patient Oriented Eczema Measure (POEM) questionnaire filled in by the participant, at baseline, after 1 and 4 months. Children aged 12 years and older complete the POEM independently, children aged 6–12 years complete it under supervision of their parents. For children under 6 years of age, parents complete the form .Itch by Peak Itch Numerical Rating Scale (PP NRS) filled in every week by the participant or their caregiver in the case of children. Children aged 12 years and older complete the PP-NRS independently, children aged 6–12 years complete it under supervision of their parents. For children under 6 years of age, parents complete the form.Quality of life (QoL), using the disease specific Dermatology Life Quality Index (IDQoL < 4 years, DCLQI 4-15 years, DLQI 16+ years) .The five-dimensional, five-level EuroQol questionnaire (EQ-5D-5L) at baseline and after 4 months. This questionnaire contain items to measure overall quality of life that are needed for the economic analysis of the ISD. Data will be collected from children aged 1-7 years by a proxy version of the EQ-5D-Y-5L, children aged 8-15 years will fill in the EQ-5D-Y-DL themselves. For children aged 16 years and older and adults the EQ-5-DL questionnaires will be used.Medication use (corticosteroids and antihistamines, using a Medication Registration Form (MRF), to register frequency and amounts of medication usage every week. Sel | — |
Countries
Netherlands
Contacts
Public ContactD Wolters
OLVG
Outcome results
None listed