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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03563300 |
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Date of registration:
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24/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Gluten-related Disorders in Familial Mediterranean Fever Patients
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Scientific title:
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Gluten-related Disorders in Patients Affected With Familial Mediterranean Fever |
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Date of first enrolment:
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September 1, 2018 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03563300 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Antonio Carroccio, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Palermo |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients, both genders, with age between 18-65 years, affected with FMF,
diagnosed according to clinical criteria designed by Livneh et al ("Tel-Hashomer"
criteria), self-reporting a relationship between their symptoms (especially
gastrointestinal) and gluten assumption, improving on a gluten-free diet and worsen on
a gluten containing diet
- Patients testing negative for celiac disease (anti-tTG and EMA negative, and with
biopsy Marsh 0-1) and wheat allergy (serum specific IgE for wheat negative)
Exclusion Criteria:
- Subjects diagnosed with celiac disease (positive anti-tTG and/or EMA, and positive
histology, with Marsh 2 or above);
- Subjects diagnosed with wheat allergy (positive serum specific IgE for wheat)
- Subjects with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis)
- Subjects with Helicobacter pylori infection and other gastrointestinal infection
- Pregnancy
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Not-celiac Wheat Sensitivity (NCWS)
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Familial Mediterranean Fever (FMF)
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Intervention(s)
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Other: Placebo Comparator
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Other: Wheat flour
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Primary Outcome(s)
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Fibromyalgia symptoms evaluation
[Time Frame: Change from baseline at 1 week]
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Gastrointestinal symptoms evaluation
[Time Frame: Change from baseline at 1 week]
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Secondary Outcome(s)
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Cytokines production
[Time Frame: Change from baseline at 1 week]
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Leukocytes cell surface antigens expression
[Time Frame: Change from baseline at 1 week]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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