Hydroponic Cultivation in Systemic Nickel Allergy Syndrome

NCT05232890 | Completed

• 1 other identifier: ID3643
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Systemic Nickel Allergy Syndrome; Hydroponic cultivation; Tomato; Quality of life; Intestinal permeability

Outcome Measures

Primary Outcomes (1)

• Change of gastrointestinal symptoms control

  Average values of the scores relating to the individual SNAS symptoms as reported in the visual analogue scale (VAS) - Systemic Nickel Allergy Syndrome (SNAS) scale before and after taking each type of tomato sauce (hydroponic vs conventional). This scale includes values from a minimum of zero to a maximum of ten. Higher scores indicate a worse outcome.

  Immediately after the intervention

Secondary Outcomes (8)

• Change of impact on quality of life - SF-36

  Change from baseline index at 12 and 26 weeks.

• Change of impact on quality of life - PGWBI

  Change from baseline index at 12 and 26 weeks.

• Change of intestinal permeability

  Change from baseline index at 12 and 26 weeks.

• Change of beta-carotene

  Change from baseline index at 12 and 26 weeks.

• Change of Vitamin D

  Change from baseline index at 12 and 26 weeks.

Study Arms (2)

Datterino tomato purée from hydroponic technology

EXPERIMENTAL

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

Other: Datterino tomato purée from hydroponic technology

Datterino tomato purée from conventional cultivation

ACTIVE COMPARATOR

100% Italian datterino tomato purée deriving from conventional cultivation.

Other: Datterino tomato puree from conventional cultivation

Interventions

Datterino tomato purée from hydroponic technology 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 hydroponic technology

Datterino tomato puree from conventional cultivation 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.

Datterino tomato purée from conventional cultivation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women who are pregnant or breastfeeding.
• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

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

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Eleonora Nucera, Prof., MD

  Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

• Angela Rizzi, MD, PhD

  Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

• Antonio Gasbarrini, Prof., MD

  Catholic University of Sacred Heart

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study product and the comparator product are provided in identical packaging, the labeling shows the randomization number which, however, only the Outcomes Assessor is able to refer to the type of treatment assigned. The organoleptic characteristics of the two products are as similar as possible. The instructions given to patients regarding the preparation and consumption of the products are the same for both products.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Allergy Unit

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: February 10, 2022
• Study Start: February 26, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 31, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)