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Search / Trial NCT05667610

Immune-supportive Diet and Gut Permeability in Allergic Children

Launched by ONZE LIEVE VROUWE GASTHUIS · Dec 19, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Gut Permeability Immune Supportive Diet Thresholds

ClinConnect Summary

This clinical trial is looking at how the health of the gut might affect children with peanut and nut allergies. Researchers want to understand why some kids react to even tiny amounts of these foods while others can tolerate more. They believe that if the gut is too “leaky” or not working properly, it may make allergies worse. The study will also explore whether a special diet that supports the immune system can help improve gut health, reduce allergy symptoms, and enhance the child's overall quality of life.

To participate, children must be between 4 and 12 years old and have had a recent positive test showing they are allergic to peanuts or nuts. They should also be potty trained. However, children with only mild symptoms, certain gastrointestinal diseases, or other specific health issues may not be eligible. If your child qualifies and joins the study, they will be closely monitored to see how their gut health and allergy symptoms change with the new diet. This research could provide valuable insights into managing food allergies in children.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • 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), lactose intolerance
  • severe cow's milk allergy -because of possible traces of cow's milk in lactose in the SAT), syndromes, infectious/immunology diseases other than atopy, or diabetes;
  • Laxative treatment, such as lactulose;
  • Not able to read or write Dutch.

About Onze Lieve Vrouwe Gasthuis

Onze Lieve Vrouwe Gasthuis (OLVG) is a leading academic medical center located in Amsterdam, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, OLVG integrates cutting-edge medical practices with rigorous scientific inquiry, aiming to enhance patient outcomes and contribute to the global body of medical knowledge. The institution emphasizes collaboration among multidisciplinary teams, ensuring that trials are conducted with the highest ethical standards and adherence to regulatory guidelines, ultimately striving to translate research findings into meaningful improvements in patient care.

Locations

Amsterdam, , Netherlands

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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