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Trial record 18 of 273 for:    personality AND therapy | Recruiting, Not yet recruiting, Available Studies

Quality of Life in Systemic Nickel Allergy Syndrome

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ClinicalTrials.gov Identifier: NCT03731494
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Eleonora Nucera, Catholic University of the Sacred Heart

Brief Summary:
This study evaluates the effects of Nickel oral hyposensitization treatment (NiOHT) on health-related quality of life (HRQoL) of patients suffered from Systemic Nickel Allergy Syndrome (SNAS).

Condition or disease Intervention/treatment
Systemic Nickel Allergy Syndrome Quality of Life Biological: Nickel oral hyposensitization treatment

Detailed Description:

Nickel (Ni) is a nutritionally essential metal widely distributed in the environment, and it has been reported to be one of the most common causes of allergic contact dermatitis (ACD), affecting nearly 15-20% of the general population. As known, Ni-hypersensitivity can induce less frequently also respiratory allergy (RA) and in approximately 20% of Ni-ACD patients cause a more complex condition termed Systemic Nickel Allergy Syndrome (SNAS). It is characterized by a combination of cutaneous (in regions without direct nickel contact) and extracutaneous gastrointestinal symptoms, after the ingestion of Ni-rich foods, especially vegetables. Then, a low-Ni diet, following positive patch tests, represents a effective diagnostic and therapeutic tool in the control of systemic manifestations, determining a significant clinical improvement.

It is known that Nickel oral hyposensitization treatment (NiOHT) is a effective approach for the management of Ni allergy, especially in a subset of patients with SNAS, inducing immunological and clinical tolerance to metal at the doses normally taken with the diet.

Although a large number of clinical trials focused on the health-related quality of life (HRQoL) in allergic disease, the expectations, the needs and the psychosocial characteristics of patients affected by SNAS are limited and no data exist pre- and post-treatment and specifically with NiOHT. Given the high safety profile and beneficial effects of immunotherapy on HRQoL of patients with allergic rhinitis, we hypothesized similar positive results even after oral Ni desensitization.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life Assessment Before and After Hyposensitization Treatment in Systemic Nickel Allergy Syndrome
Actual Study Start Date : March 2015
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Nickel

Group/Cohort Intervention/treatment
Nickel oral hyposensitization treatment
The patients take capsules at different doses in nickel content until reaching the maximum dose of 1.5 mcg per week for a total of 12 months.
Biological: Nickel oral hyposensitization treatment
Nickel oral hyposensitization treatment (NiOHT) was performed with hard gelatin capsules containing Nickel sulphate (NiSO4) at different dosages (0.1 ng, 1 ng, 10 ng, 0.1 μg, 0.5 μg) and microcrystalline cellulose as excipient (TIO Nickel, Lofarma SpA, Milan, Italy). Treatment was given 3 times a week increasing progressively the dose from 0.1 ng to 3 μg in 10 weeks with a maintenance phase of 1,5 μg a week for a period of 12 months. After 6 months, patients were allowed to gradually reintroduce nickel-rich foods, starting with those with a maximum of 100 mcg of nickel content. For all the treatment period, information on the appearance of side effects or more severe adverse reactions and the need for antiallergic drugs (corticosteroids, antihistamine drugs) were collected.
Other Name: NiOHT - TIO Nickel




Primary Outcome Measures :
  1. QoL: Short-Form 36-Item Health Survey (SF-36v2) [ Time Frame: Change from baseline index at 12 months ]
    Short-Form 36-Item Health Survey (SF-36v2) is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively.

  2. QoL: Psychological General Well Being Index (PGWBI) [ Time Frame: Change from baseline index at 12 months ]
    The PGWBI consists of 22 questions, which deal with six factors (anxiety, depression, vitality, general health,self-control and well-being) constituting a global assessment.The response format is graded 1-6 (i.e. total range 22-132), with the highest value corresponding to optimal well-being.


Secondary Outcome Measures :
  1. Psychological state: Minnesota Multiphasic Personality Inventory (MMPI-2) [ Time Frame: Baseline. ]
    The MMPI-2 questionnaire containing 567 items with 2 choices of answer ("true" or "false") in order to assess the main structural features of personality and emotional disorders.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The Researchers enrol patients suffer from Systemic Nickel Allergy Syndrome (SNAS), condition characterised by a combination of cutaneous (in regions without direct nickel contact) and extracutaneous gastrointestinal symptoms, after the ingestion of Nickel-rich foods, especially vegetables.
Criteria

Inclusion Criteria:

  • history of SNAS (coexistence of typical cutaneous and gastrointestinal symptoms),
  • positive Ni-patch test,
  • clinical improvement at least 70% from baseline after 4 weeks on a low-Ni diet,
  • positivity of a double blind placebo-controlled oral Ni challenge (DBPCO),
  • written informed consent.

Exclusion Criteria:

  • age < 18 years and > 65 years,
  • other organic gastrointestinal diseases, such as peptic ulcer, inflammatory bowel diseases, celiac disease, gastrointestinal infections, and small intestinal bacterial overgrowth,
  • diabetes mellitus,
  • hepatic, renal or cardiac dysfunction,
  • thyroid disease or tumor,
  • concomitant treatment with steroids and/or antihistamines in the previous 4 weeks, pregnancy, lactation,
  • smoking, abuse of alcohol, coffee, tea, and cola intake,
  • refusal to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731494


Contacts
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Contact: Eleonora Nucera, MD,Prof 00390630154965 eleonora.nucera@unicatt.it
Contact: Angela Rizzi, MD,PhD 00390630154965 angelarizzi81@gmail.com

Locations
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Italy
Catholic University of Sacred Heart Recruiting
Roma, Italy, 00168
Contact: Eleonora Nucera, MD,Prof    003930154965    eleonora.nucera@unicatt.it   
Contact: Angela Rizzi, MD,PhD    003930154965    angelarizzi81@gmail.com   
Sub-Investigator: Angela Rizzi, MD,PhD         
Sub-Investigator: Alessia Di Rienzo, MD         
Sub-Investigator: Riccardo Inchingolo, MD,PhD         
Sub-Investigator: Domenico Schiavino, MD,Prof         
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Eleonora Nucera, MD,Prof Catholic University of Sacred Heart
Study Director: Antonio Gasbarrini, MD,Prof Catholic University of Sacred Heart

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Responsible Party: Eleonora Nucera, Prof., Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT03731494     History of Changes
Other Study ID Numbers: 1377/15 (13939/14)
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eleonora Nucera, Catholic University of the Sacred Heart:
Nickel allergy
Systemic nickel allergy syndrome
Health-related quality of life
Nickel oral hyposensitizing treatment
Diet
Short-Form 36-Item Health Survey
Psychological General Well Being Index
Minnesota Multiphasic Personality Inventory

Additional relevant MeSH terms:
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Syndrome
Hypersensitivity
Disease
Pathologic Processes
Immune System Diseases
Nickel
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs