to study, in adults with moderate to severe AD,: 1. the effect of an immune-supportive diet on severity of AD (including itch), cytokine production, quality of life, use of medication and nutritional intake;2. the dietary compliance and feasibility…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
main study outcomes (no primary outcome):
Differences in AD severity (including itch), cytokine production, quality of
life, nutrition intake and use of medication.
Secondary outcome
n.a.
Background summary
Atopic dermatitis (AD) is a chronic disease characterized by visible skin
lesions and intense itching that causes serious disease burden in patients,
both mentally and physically. There is no complete cure for AD and therefore
management currently focuses on avoidance of triggers (e.g. bathing), skin
hydration, and reduction of skin inflammation. The relationship between AD and
diet and nutrition is complex and unclear and the evidence is scarce.
Elimination diets are rarely significantly effective. However, patients with AD
often follow unsupervised elimination diets. An immune-supportive diet may
ameliorate AD because of the anti-inflammatory effects of the total diet,
direct effects of specific nutrients or food components on innate and adaptive
immune cells and the role of nutrition in the gut microbiome and gut
permeability.
Study objective
to study, in adults with moderate to severe AD,:
1. the effect of an immune-supportive diet on severity of AD (including itch),
cytokine production, quality of life, use of medication and nutritional intake;
2. the dietary compliance and feasibility of the immune-supportive diet.
Study design
: A multicentre non-randomised proof-of-concept study on severity of AD in
adult patients who visit the outpatient clinics of the dermatology departments
of OLVG or AUMC.
Intervention
Patients will receive written and oral dietary advice by an allergy-specialist
dietitian regarding the maintenance of a healthy and individually tailored
immune-supportive diet during 4 months (including 1 month run in), supported by
sample menus, recipes and product information.
At baseline and at the end of the study, AD severity will be measured by the
dermatologist and scored by the patient. Cytokines in the skin will be
determined by tape striping, quality of life will be scored. Nutrition intake
will be recorded by the patients using 3-day food diaries.
Itch and medication use will be scored on a weekly base. After 4 weeks of
run-in diet the patients will score the AD severity to monitor the (placebo)
effect of enrolment
Study burden and risks
An immune supportive diet is a healthy diet and does not bring any extra risks
for the participants. Participating in this study will yield some burden: extra
time for dietary adherence and measurements, extra costs (15% extra) and
restricted food choices.
However, patients will be reimbursed for extra costs and the dietician will
ensure sufficient tasteful and acceptable alternatives. If effective, disease
severity including itch will decrease and may heavily outweigh this burden.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
Inclusion criteria
- Age 18 years or older
- Diagnosed with moderate to severe AD by the dermatologist, EASI score
7.1-72.
- Able to speak and write Dutch.
Exclusion criteria
- Other skin diseases
- Not able to speak or write Dutch fluently;
- Pregnancy;
- Multiple clinical relevant IgE mediated food allergies (> 1 staple food or
food group, such as cow*s milk or nuts/peanuts/seeds);
- Avoidance of all dairy or gluten;
- Extensive eliminations due to Pollen Food Syndrome, so that a daily variety
of raw fruits and/or vegetables is not feasible;
- Individual patients will not start the dietary intervention just before
the time of the year in which the AD is usually worsening.
- Antibiotics shorter than 6 weeks prior to the study;
- Using systemic immune suppressants or biologicals;
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85507.100.23 |