Effect of an Immune-supportive Diet on Gut Permeability and Allergic Symptoms in Children With Peanut and/or Nut Allergy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 17
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Netherlands
OLVG
RECRUITING
Amsterdam
Contact Information
Primary
Berber Vlieg-Boerstra
b.vlieg-boerstra@olvg.nl
+31620965612
Backup
Chantal den Elzen, MSc
c.denelzen@olvg.nl
+31627538421
Time Frame
Start Date: 2022-09-08
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 132
Treatments
Experimental: Intervention group (immune-supportive diet)
* Immune-supportive diet (for 4 months) on top of peanut and/or nut free diet. Foods are allocated into 3 food groups:~ 1. Recommended in ample amounts: with an acknowledged beneficial role in immune health (first choice foods);~ 2. Recommended in limited amounts: with an acknowledged beneficial role in immune health when used in limited amounts (second choice foods).~ 3. Not recommended: with an acknowledged unfavourable role in immune health (third choice foods)~* Self-assessed feasibility and adherence to the Immune-supportive diet (intervention group only) a by Likert scale after 2,5 and 4 months of dietary intervention;~* Dietary adherence will be determined by the researchers after 4 months by calculating the number of first and second choice foods based on the food diaries after dietary intervention.
Active_comparator: Control group
\- Peanut and/or nut free diet only
Sponsors
Collaborators: Deventer Ziekenhuis, Utrecht Institute for Pharmaceutical Sciences, Noordwest Ziekenhuisgroep, Ekhaga foundation, Amsterdam UMC, Diakonessenhuis, Utrecht, Erasmus Medical Center, Rijnstate Hospital, Wageningen University, Harvard University
Leads: Onze Lieve Vrouwe Gasthuis

This content was sourced from clinicaltrials.gov