Allergy Clinical Trial
Official title:
Systemic Nickel Allergy Syndrome: Intervention Study for the Assessment of the Dietary Indications
Verified date | June 2021 |
Source | University of Pavia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Nickel is a silvery metal widely used in nature and contained in many foods. Exposure to nickel is responsible for two different types of adverse reactions: Allergic Contact Dermatitis (DAC) and Systemic Nickel Allergy Syndrome (SNAS). The latter is characterized by the presence of extra-cutaneous manifestations, in addition to the skin lesions of the DAC, related to the introduction of nickel-containing foods. Therefore, a nutritional intervention is essential to reduce the symptoms of SNAS. Currently in the literature there are no nutritional guidelines on the treatment and management of patients suffering from SNAS and often the indications provided to patients involve the exclusion of groups of foods for prolonged periods, with the consequent risk of developing nutritional deficiencies and malnutrition. Objectives: to evaluate the efficacy of dietary indications, developed on the most recent scientific evidence, useful for the management of the symptoms associated with adverse reactions to Nickel. Provide practical indications to specialist staff in multidisciplinary patient management and make the patient aware of his problem and help him understand how to manage it independently. Target population: subjects over the age of 18, female, belonging to the U.O. Occupational Medicine Allergology Section at ICS Maugeri of Pavia, with previous diagnosis of Nickel allergy (patch test) and with the presence of gastrointestinal symptoms related to allergy.
Status | Completed |
Enrollment | 53 |
Est. completion date | December 1, 2020 |
Est. primary completion date | November 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients on first access aged 18 or over; - nickel phosphate sensitized patients (patch test: ++ or +++); - monosensitized or polisensitized patients; - patients with the presence of allergic gastrointestinal symptoms; - patients negative to diagnostic tests for other allergies; - signature of informed consent. Exclusion Criteria: - patients positive for diagnostic tests for other allergies; - polysensitized patients with additives and preservatives, to exclude any confounding effects; - patients who have previously received dietary indications for allergy management; - patients who have been diagnosed with IBD (Irritable Bowel Disease) such as Ulcerative Rectocolitis, Chron's disease, IBS; - patients in whom a Eating and Nutrition Disorder (DAN) has been diagnosed; - patients with malignancies. |
Country | Name | City | State |
---|---|---|---|
Italy | Istituti Clinici Scientifici Maugeri SpA | Pavia | Lombardia |
Lead Sponsor | Collaborator |
---|---|
University of Pavia | Istituti Clinici Scientifici Maugeri SpA |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | protocol nickel free | to evaluate the efficacy of dietary indications, developed on the most recent scientific evidence, useful for the management of the symptoms associated with adverse reactions to nickel.
Throughout the study: therefore during the first phase in which a nickel free diet is followed and during the second phase of gradual reintegration of food containing nickel, patients must fill in a diary of what they eat weekly. The efficacy of dietary indications is evaluated using the visual analog scale. Both the symptoms related to the gastro intestinal system (nausea, diarrhea, vomiting, bloating of the intestine), and those extra intestinal such as headache, itching are evaluated. |
2 years | |
Secondary | Nickel free diet and symptoms | verify the correlation between the consumption of a specific food and the onset of gastroenteric symptoms, using a dietary in wich the patien described what they eat and their specific symptoms | 2 years |
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