Health TrialsbyHealthPanel

Immune-supportive Diet and Gut Permeability in Allergic Children

ConditionsPeanut AllergyNut Allergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorOnze Lieve Vrouwe Gasthuis

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children of 3 to 17 years of age with a positive open or double-blind placebo-controlled peanut or nut challenge < 12 months to inclusion OR an obvious and objective IgE-mediated allergic reaction following the consumption of isolated peanut or nut within 1 hours, confirmed by sensitisation to peanut or nut < 24 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.

Disqualifiers

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), lactose intolerance

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immune-supportive diet

    Other intervention

    The intervention includes a immune-supportive diet over a period of 4 months

  • Standard care

    Other intervention

    Standard care: Peanut or nut free diet

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Intervention group (immune-supportive diet)Experimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
4 months

Secondary outcomes

1

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

Time frame
At baseline
2

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)

Time frame
At baseline
3

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

Time frame
At baseline
4

Relationship between gut permeability and treshold levels to peanut or nuts

The relationship between gut permeability (R/M ratio) and threshold level to peanut or nuts established during the oral food challenge (cumulative mg peanut or nut protein);

Time frame
At baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Onze Lieve Vrouwe Gasthuis

Lead sponsor

Ekhaga foundation

Collaborator

Rijnstate Hospital

Collaborator

Noordwest Ziekenhuisgroep

Collaborator

Erasmus Medical Center

Collaborator

Wageningen University

Collaborator

Amsterdam UMC

Collaborator

Utrecht Institute for Pharmaceutical Sciences

Collaborator

Diakonessenhuis, Utrecht

Collaborator

Deventer Ziekenhuis

Collaborator

Harvard University

Collaborator

Source ClinicalTrials.gov
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