Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|4 Years - 12 Years
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Onze Lieve Vrouwe Gasthuis
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Peanut Allergy, Nut Allergy
The incidence of allergic asthma, atopic dermatitis and food allergy started to grow to epidemic proportions after the 1960s. Peanut and nut allergy are common food allergies. Peanut allergy affects 1.4 to 3.0% of the children. Peanut and nut allergy are often lifelong and may be severe. Peanut allergy is the leading cause of (fatal) food anaphylaxis. Once peanut and nut allergy have developed, there is currently no cure other than adhering to an avoidance diet and carrying and using intramuscular epinephrine or oral antihistamines in the case of accidental ingestion. Oral immunotherapy with peanut or nuts is only applied in research setting, however, it has several drawbacks and is still in its infancy. Inter- and intra-individual differences in threshold in peanut allergy: Threshold levels for peanut and nuts, the lowest amount of peanut or nuts causing a reaction, may largely vary between allergic children, for which there is no clear explanation. Thresholds can be determined during oral food challenge tests with peanut or nuts in the hospital. An international multi-center study found that 5% of the children react to a low threshold of 1.7 mg of peanut protein during the food challenge in the hospital, 7.4 mg of cashew nut protein and 0.29 mg of hazelnut protein during a food challenge in the hospital. These are only traces, while 50% react to 67 mg of peanut protein. This is around 1⁄3 of a peanut, thus also a small amount. These threshold levels demonstrate how careful patients have to be in their dietary behavior. Patients with a low threshold are very sensitive to peanut or nuts and are at greater risk to react to traces of allergenic protein which can be intentionally or unintentionally present in prepacked or unpacked food. Studies have shown that the lower the threshold, the greater the impact on the health-related quality of life of the child and their parents. It is poorly understood how these differences in sensitivity (threshold levels) between individuals can be explained. Sensitization to peanut or nuts, as demonstrated by levels specific immunoglobulin E (IgE) for peanut by blood testing or the size of the skin prick test with peanut or nuts cannot explain the difference in threshold level, because they have a low predictive value for the threshold. Infection diseases illness, exercise and sleep deprivation significantly reduce the threshold level in allergic adults. However, these co-factors are not relevant in all patients, specifically not in children, and cannot explain the large differences in threshold levels observed. Peanut and nut allergy coincides with other atopic disease: Peanut and nut allergic children frequently suffer from other food allergies, such as milk and egg, and other coexisting atopic (allergic) diseases such as atopic dermatitis, allergic rhinitis (hay fever) and allergic asthma, leading to a substantial allergic burden in children with peanut and nut allergy. Because of the burden of these allergic conditions, the quality of life of children with food allergy is decreased, however underestimated. and even lower compared to chronic diseases, e.g. lower than children with diabetes. All these coexisting allergic diseases are based on immunologic and chronic inflammatory processes. Asthma is a systemic inflammatory disorder with a close link between the upper and the lower airways. The majority of patients with asthma have concomitant rhinosinusitis. The respiratory system is also under the influence by co-morbid conditions related to the gastrointestinal tract (food sensitization, bowel inflammation), the skin (eczema, barrier dysfunction) as well as the nervous system (neuroimmunologic network, cognitive dysfunction). Defective mucosal barrier function (leaky gut) or increased gut permeability as possible explanation for high prevalence of allergic disease and differences in threshold to peanut or nuts: The steep increase of allergic diseases is attributed to several lifestyle changes due to urbanization and modernization, caesarean section, use of antibiotics, a westernized pro-inflammatory diet and obesity. Firstly, according to the generally accepted hypotheses, i.e. the hygiene hypothesis and the biodiversity hypothesis, all these changes lead to microbial dysbiosis and loss of microbial diversity in the gut, which are major reasons for inflammation, inappropriate immune responses and disease development, because there is a continuous crosstalk between the intestinal microbiome and our immune system through immunomodulatory signals. Allergic diseases, such as food allergy, asthma and atopic dermatitis are all characterized by a dysbiosis and reduced diversity of the microbiome. Secondly, one of the most recent additional explanations for the increased prevalence of allergic disease is a defective epithelial (=mucosal) barrier in the skin, gut and lungs (the "extended epithelial barrier hypothesis"). Impaired mucosal barrier function, or "leaky gut" , which results in increased gut permeability, is caused by epithelial-damaging substances linked to industrialization, urbanization and modern life, such as household and dishwashing cleaning agents and the use of (ultra) processed foods through, amongst others, emulsifiers. An intact mucosal barrier is crucial for the maintenance of tissue homeostasis as this protects against allergens. An increased gut permeability can result in an enhanced uptake of allergens where they may activate the immune system leading to severe chronic inflammation. Thus, it is well possible that an impaired mucosal barrier function may contribute to these observed differences in threshold to peanut and nuts. Mucosal barrier dysfunction has been demonstrated in asthma, chronic rhinosinusitis, atopic dermatitis, and Eosinophilic Esophagitis (EoE) and a number of studies in food allergy. Both the Lactulose/Mannitol ratio in urine (L/M ratio) as well as the Raffinose/Mannitol ratio in urine (R/M ratio) are commonly used Sugar Absorption Tests (SAT) for the analysis of small intestinal permeability. In the Netherlands the R/M ratio has been implemented as sugar absorption test (SAT) and is provided by Good Manufacturing Practice (GMP) certified pharmacists. If the mucosal integrity is impaired the urinary excretion of Raffinose will increase (see methods for more details). In children, for example, increased gut permeability in milk- and egg allergic children was found as compared to 7 controls. Similar results were found by Andre et al in children and adults with sensitization to foods, 0,6
- - 70 years.
Experimental: Intervention group (immune-supportive diet)
Immune-supportive diet (for 4 months) on top of peanut and/or nut free diet Feasibility of adherence to the Immune-supportive diet (intervention group only) and dietary compliance by Likert scale after 2,5 and 4 months of dietary intervention (2x)
Active Comparator: Control group
- Peanut and/or nut free diet only
Other: - Immune-supportive diet
The intervention includes a immune-supportive diet over a period of 4 months
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.