CompletedNot Applicable

Gluten-related Disorders in Familial Mediterranean Fever Patients

Italy8 participantsStarted 2018-09-01

Plain-language summary

It is known that the gluten-containing grains can be responsible for human diseases related to gluten exposure. These forms of gluten intolerance represent a heterogeneous set of conditions, including celiac disease (CD), wheat allergy (WA) and not celiac gluten sensitivity (NCGS), that combined seems to affect about 5-10% of the general population. NCGS is the most recent gluten-related disease, characterized by intestinal and extra-intestinal symptoms related to the ingestion of gluten-containing food, in subjects in whom either celiac disease or wheat allergy previously has been excluded. However, as it is not known what component of the cereals causes the symptoms in NCGS patients, the investigators prefer the label of "Not-celiac wheat sensitivity" (NCWS). Typically, the NCWS diagnosis is made by exclusion. Furthermore, similarly to CD, the investigators had demonstrated that NCWS may be associated with other autoimmune disease (i.e. Hashimoto's thyroiditis). Among these autoimmune conditions, in our daily out clinic work, the investigators have observed an association between self-reported NCWS and Familial Mediterranean Fever (FMF). Our preliminary observational data indicate that some FMF patients relate their symptoms (especially gastrointestinal) to gluten assumption, then excluding it from diet and using gluten-free products, with partial remission of gastrointestinal symptoms. Therefore, FMF and NCGS share some clinical features, such as abdominal pain, diarrhea, arthralgia and arthritis, and tend to be commonly associated with other inflammatory and autoimmune diseases. This study has 2 major aims: 1.To evaluate the real relationship between the wheat ingestion and the gastrointestinal manifestations presented by FMF patients, self-reporting a NCWS. 2. To identify possible immunologic markers that may explain the mechanism underling FMF abdominal attack and wheat ingestion.

Who can participate

Age range18 Years – 65 Years

SexALL

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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

What they're measuring

Fibromyalgia symptoms evaluation

Timeframe: Change from baseline at 1 week

Gastrointestinal symptoms evaluation

Timeframe: Change from baseline at 1 week

Trial details

NCT IDNCT03563300

SponsorUniversity of Palermo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-01

View on ClinicalTrials.gov More Not-celiac Wheat Sensitivity (NCWS) trials