Peanut Allergy Clinical Trial
— DIAMETEROfficial title:
Effect of an Immune-supportive Diet on Gut Permeability and Allergic Symptoms in Children With Peanut and/or Nut Allergy
Peanut and nut allergy can be life threatening. Some patients have very low threshold levels (i.e. the amounts of peanut and nuts to which the patients react), others react to higher doses. The reasons for these differences in threshold are not well understood. Patients with peanut and nut allergy often suffer from other allergic diseases (atopic dermatitis, hay fever and asthma). A disturbed gut microbiota composition and an increased gut permeability may explain the development of allergic disease. We hypothesize that increased gut permeability is related to low threshold levels to peanuts or nuts. In addition, as it is known that nutrition can influence our gut permeability, we also hypothesize that a healthful immune-supportive diet restores gut permeability and alleviates symptoms. Therefore, the purpose of the study is to study in peanut and nut allergic children: 1. the relationship between gut permeability and threshold levels to peanut or nuts; 2. the effect of an immune-supportive diet on gut permeability, gut microbiome composition, coexisting allergic symptoms and quality of life
Status | Recruiting |
Enrollment | 132 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility | Inclusion Criteria: - Children of 4 to 12 years of age with a positive open or double-blind placebo-controlled peanut or nut challenge < 12 months to inclusion; - Children who are potty trained or house trained; - Presence of IgE to peanut =0.35 kilo units per liter (kU/l) or skin prick test > 3 mm to peanut or nut, < 12 months prior to challenge. Exclusion Criteria: - Only mild symptoms in the oral cavity to peanut or nut due to pollen food syndrome; - A negative peanut or nut challenge; - Children who are not potty trained (house trained); - Gastro-intestinal diseases (e.g. Morbus Crohn, coeliac disease, Colitis Ulcerosa), syndromes, infectious/immunology diseases other than atopy, or diabetes; - Laxative treatment, such as lactulose; - Not able to read or write Dutch. |
Country | Name | City | State |
---|---|---|---|
Netherlands | OLVG | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Onze Lieve Vrouwe Gasthuis | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Ekhaga foundation, Erasmus Medical Center, Noordwest Ziekenhuisgroep, Rijnstate Hospital, Wageningen University |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in small intestine permeability between baseline and after 4 months of dietary intervention as expressed by the Raffinose/Mannitol ratio in urine | We will measure the ratio of Raffinose/Mannitol in urine at baseline and after 4 months of dietary intervention | 4 months | |
Secondary | Relationship between gut permeability and the severity of atopic dermatitis | Gut permeability is measured by R/M ratio. Severity of atopic dermatitis is measured by SCORAD | At baseline and at 4 months | |
Secondary | Relationship between gut permeability and patient reported outcomes of atopic dermatitis | Gut permeability is measured by R/M ratio. Severity of atopic dermatitis is measured by Patient-Oriented Eczema Measure (POEM) questionnaire | At baseline and 4 months | |
Secondary | Relationship between gut permeability and patient reported outcomes of asthma and allergic rhinitis | Gut permeability is measured by R/M ratio. Severity of Asthma and allergic rhinitis symptoms are measured by the Onderzoek astma en hooikoorts bij kinderen questionnaire (Caratkids) | At baseline and 4 months | |
Secondary | Relationship between gut permeability and patient reported outcomes of gastrointestinal symptoms | Gut permeability is measured by R/M ratio. Gastrointestinal symptoms are measured by the Birmingham irritable bowel syndrome (IBS) questionnaire in Dutch | at baseline and at 4 months | |
Secondary | Relationship between gut permeability and food allergy quality of Life will be measured by disease-specific and age-related quality of life | Gut permeability is measured by R/M ratio. Food allergy quality of life will be measured by disease-specific and age-related quality of life questionnaires (FAQLQ-ChildForm, FAQLQ-ParentForm and FAQLQ-TeenagerForm)
Differences in gut microbiota composition between baseline and after 4 months of dietary intervention |
At baseline and at 4 months | |
Secondary | Feasibility of adherence to the Immune-supportive diet (intervention group only) | Feasibility of adherence to the Immune-supportive diet (intervention group only) will be measured by by Likert scale | 4 months | |
Secondary | Dietary compliance to the Immune-supportive diet (intervention group only) | Dietary compliance to the Immune-supportive diet (intervention group only) will be measured by Likert scale | 4 months | |
Secondary | Differences in use of medications | Use of medication will be registered by a Medication Registration Form (MRF). | 4 months | |
Secondary | Differences in nutritional intake | Dietary intervention (in grams of food) will be assessed by three online 24-hour food recalls | At baseline and after 4 months | |
Secondary | Differences in gut microbiota composition | Microbiota compostion will be measured by by gene sequencing technology (16S( methods | At baseline and after 4 months | |
Secondary | Relationship between gut permeability and threshold level to peanut or nuts | Gut permeability is measured by R/M ratio Threshold level to peanut or nuts will be established by oral open or double-blind food challenge (cumulative mg peanut or nut protein); | Baseline | |
Secondary | Relationship between gut permeability and nutritional intake | Gut permeability is measured by R/M ratio Dietary intervention (in grams of food) will be assessed by three online 24-hour food recalls | At baseline and after 4 months |
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