Hydroponic Cultivation in Systemic Nickel Allergy Syndrome

NCT ID: NCT05232890

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2022-03-31

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.

Conditions

Food Allergy; Food Hypersensitivity; Nickel Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Datterino tomato purée from hydroponic technology

100% Italian datterino tomato purée deriving from hydroponic technology (soilless) with particular characteristics such as nickel free and zero residue.

Group Type: EXPERIMENTAL

Datterino tomato purée from hydroponic technology

Intervention Type: OTHER

Daily intake of minimum 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from hydroponic technology (soilless), contained in a 720ml bottle.

Datterino tomato purée from conventional cultivation

100% Italian datterino tomato purée deriving from conventional cultivation.

Group Type: ACTIVE_COMPARATOR

Datterino tomato puree from conventional cultivation

Intervention Type: OTHER

Daily intake of at least 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from conventional cultivation, contained in a 720 ml bottle.

Interventions

Datterino tomato purée from hydroponic technology

Daily intake of minimum 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from hydroponic technology (soilless), contained in a 720ml bottle.

Intervention Type: OTHER

Datterino tomato puree from conventional cultivation

Daily intake of at least 100ml - maximum 200ml of 100% Italian datterino tomato puree deriving from conventional cultivation, contained in a 720 ml bottle.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Eleonora Nucera

Head of Allergy Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eleonora Nucera, Prof., MD

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Sacred Heart

Angela Rizzi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Sacred Heart

Antonio Gasbarrini, Prof., MD

Role: STUDY_DIRECTOR

Catholic University of Sacred Heart

Locations

UOSD Allergologia e Immunologia Clinica, Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, , Italy

Countries

Italy

Other Identifiers

ID3643

Identifier Type: -

Identifier Source: org_study_id