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临床试验/NCT05667610
NCT05667610招募中不适用

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

Onze Lieve Vrouwe Gasthuis1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2022年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
132
试验地点
1
主要终点
Changes in small intestine permeability between baseline and after 4 months of dietary intervention as expressed by the Raffinose/Mannitol ratio in urine

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

The participants are randomly assigned to an intervention group or control group via castor.edc.

入排标准

年龄范围
3 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Changes in small intestine permeability between baseline and after 4 months of dietary intervention as expressed by the Raffinose/Mannitol ratio in urine

时间窗: 4 months

We will measure the ratio of Raffinose/Mannitol in urine at baseline and after 4 months of dietary intervention

次要结局

  • Relationship between gut permeability and the severity of atopic dermatitis(At baseline)
  • Relationship between gut permeability and patient reported outcomes of asthma and allergic rhinitis(At baseline)
  • Relationship between gut permeability and patient reported outcomes of gastrointestinal symptoms(At baseline)
  • Relationship between gut permeability and treshold levels to peanut or nuts(At baseline)
  • Differences in gut microbiota composition(At baseline and after 4 months)
  • Differences in severity of atopic dermatitis(At baseline and after 4 months)
  • Differences in atopic dermatitis (POEM)(At baseline and after 4 months)
  • Differences in asthma(At baseline and after 4 months)
  • Differences in gastro-intestinal symptoms(At baseline and after 4 months)
  • Differences in use of medications(At baseline and after 4 months)
  • Differences in upper respiratory tract infections (URTIs)(At baseline and after 4 months)
  • Differences in food allergy quality of Life(At baseline and after 4 months)
  • Self-assessed dietary adherence and feasibility of the Immune-supportive diet (intervention group only)(2,5 and 4 months)
  • Relationship between gut permeability and nutritional intake(At baseline and after 4 months)
  • Calcultated dietary adherence(At baseline and after 4 months)

研究者

发起方
Onze Lieve Vrouwe Gasthuis
申办方类型
Other
责任方
Sponsor

研究点 (1)

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