Clinical trial NCT05232890: Hydroponic Cultivation in Systemic Nickel Allergy Syndrome
Official title: Hydroponic Cultivation: a New Dietary Frontier in Systemic Nickel Allergy Syndrome - a Double Blind, Randomized, Controlled, Cross-over, Clinical Trial on the Use of Hydroponic Cultivated Tomato Sauce
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Food Hypersensitivity
Nickel Sensitivity
Keywords: Systemic Nickel Allergy Syndrome
Hydroponic cultivation
Tomato
Quality of life
Intestinal permeability
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients with documented diagnosis of SNAS: a) history of SNAS (coexistence of typical skin symptoms and gastrointestinal symptoms); b) positive nickel sulphate patch test; c) clinical improvement of at least 70% after 4-6 weeks of low-nickel diet; d) positivity of the oral challenge test with nickel sulphate.
* Age between 18 and 65 years.
* Written informed consent to participate in the study.
* Patients who are able to participate in all study procedures and to accept and comply with all study needs throughout the study, including the availability of suitable transportation and the time required to undergo all procedures. planned visits.

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Patients diagnosed with organic diseases capable of affecting gastrointestinal symptoms (eg celiac disease, poorly controlled diabetes, scleroderma, chronic inflammatory bowel diseases). Lactose intolerance is not an exclusion criterion if the diagnosis has been made for more than 6 months and if the patient does not report adequate symptom relief after at least 6 months of a lactose-free diet.
* Patients who have been taking systemic probiotics, antibiotics or systemic corticosteroids within the past 30 days.
* Patients who have been taking antidepressant or anxiolytic drugs for less than a month. On the other hand, patients can be enrolled who have been taking the aforementioned drugs at a stable dosage for at least one month.
* Patients who abuse coffee, tea, coca cola and with a smoking habit.
* Patients with pacemakers because they cannot be subjected to bioimpedance analysis for the assessment of body composition.

Primary outcomes:
measure: Change of gastrointestinal symptoms control
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Change of impact on quality of life - SF-36
timeFrame: Change from baseline index at 12 and 26 weeks.
measure: Change of impact on quality of life - PGWBI
timeFrame: Change from baseline index at 12 and 26 weeks.
measure: Change of intestinal permeability
timeFrame: Change from baseline index at 12 and 26 weeks.
measure: Change of beta-carotene
timeFrame: Change from baseline index at 12 and 26 weeks.
measure: Change of Vitamin D
timeFrame: Change from baseline index at 12 and 26 weeks.
measure: Change of hemoglobin
timeFrame: Change from baseline index at 12 and 26 weeks.
measure: Change of ferritin
timeFrame: Change from baseline index at 12 and 26 weeks.
measure: Change of adherence
timeFrame: After 12 weeks, after 26 weeks.
Other outcomes:
Locations:
city: Roma
country: Italy
facility: UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Catholic University of Sacred Heart
name: Eleonora Nucera, Prof., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of Sacred Heart
name: Angela Rizzi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of Sacred Heart
name: Antonio Gasbarrini, Prof., MD
role: STUDY_DIRECTOR
References: