Hydroponic Cultivation in Systemic Nickel Allergy Syndrome
Condition: Food Allergy; Food Hypersensitivity; Nickel Sensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      Oral intake of nickel (Ni) is capable of causing the onset of systemic disorders in patients
      with Systemic Allergy to Nickel Syndrome (SNAS), an emerging allergic condition. Given its
      ubiquitous age, it is not possible to completely eliminate Ni and, therefore, it is necessary
      to plan a low-content diet. However, due to various factors (such as variability of Ni
      concentration in the soil, individual foods, variability of dietary habits and daily menus,
      different intake of Ni contained in the water, different intake of kitchen utensils,
      simultaneous intake of other substances), a restrictive diet is difficult and socially
      discriminating with a strongly negative impact on the quality of life of these patients.

      Hydroponic agriculture in a completely controlled, aseptic, artificial, soilless environment
      could be an alternative for patients suffering from SNAS with known and lower concentrations
      of metals than those deriving from conventional agricultural techniques, which are affected
      by the soil of origin and practices cultivation.

      The primary outcome of the study is to evaluate the possible effects of taking tomato puree
      deriving from hydroponic agriculture compared to tomato puree from conventional cultivation
      in the subjective control of SNAS symptoms, in patients following a low-diet diet.

      This is an interventional, randomized, double-blind, single-center crossover study involving
      a cohort of SNAS patients following a low-nickel diet for at least 4-6 weeks.
    


Intervention name(s): Datterino tomato purée from hydroponic technology; Datterino tomato puree from conventional cultivation
Intervention type(s): Other; Other
Intervention description(s): Daily intake of minimum 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from hydroponic technology (soilless), contained in a 720ml bottle.; Daily intake of at least 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from conventional cultivation, contained in a 720 ml bottle.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: At enrollment, patients are randomized to one of the following study groups: Group A and Group B:
Treatment arm A: daily intake of minimum 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from hydroponic technology (soilless), contained in a 720ml bottle.
Treatment arm B: daily intake of minimum 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from conventional cultivation, contained in a 720ml bottle.
After this initial treatment phase, both study groups follow a 2-week wash-out period, following a low-nickel diet.
At the end of the wash-out phase, the two groups cross-over. Therefore, Group A is assigned to treatment arm B, and vice versa, for a period of 12 weeks.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Systemic Nickel Allergy Syndrome; Hydroponic cultivation; Tomato; Quality of life; Intestinal permeability