Gynaecological Disorders in Not-celiac Wheat Sensitivity
Condition: Non-celiac Wheat Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      In the last few years, a new clinical entity has emerged which includes patients who consider
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
      they do not have celiac disease (CD) or wheat allergy. This clinical condition has been named
      non-celiac gluten sensitivity (NCGS), although in a recent article, the investigators
      suggested the term "non-celiac wheat sensitivity" (NCWS), because it is not known to date
      what component of wheat actually causes the symptoms. The clinical picture of NCWS is
      characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or
      constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and very
      different extra-intestinal and systemic manifestations (headache, depression, anxiety, 'foggy
      mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm
      numbness, and anemia). Nowadays, there no data about a possible relationship between
      gynaecological disorders and food ingestion and food allergy/intolerance. Therefore, the aims
      of the present study are to investigate 1) the prevalence and characteristics of
      gynaecological disorders in NCWS patients compared to CD and irritable bowel syndrome (IBS)
      controls, and 2) the modification of such disorders in NCWS patients after a gluten
      (wheat)-free diet.
    

Detailed description: 
      In the last few years, a new clinical entity has emerged which includes patients who consider
      themselves to be suffering from problems caused by wheat and/or gluten ingestion, even though
      they do not have CD or wheat allergy. This clinical condition has been named non-celiac
      gluten sensitivity (NCGS), although in a recent article, the investigators suggested the term
      "non-celiac wheat sensitivity" (NCWS), because it is not known to date what component of
      wheat actually causes the symptoms. Other areas of doubt in NCWS regard its pathogenesis,
      while some papers reported intestinal immunologic activation, others linked NCWS to the
      dietary short chain carbohydrate (fermentable oligo-di-monosaccharides and polyols, FODMAPs)
      load. The investigators recently demonstrated that higher proportions of patients with NCWS
      develop autoimmune disorders, are antinuclear antibodies (ANA) positive, and show DQ2/DQ8
      haplotypes compared with patients with IBS, supporting an immunologic involvement in NCWS.
      The clinical picture of NCWS is characterized by combined gastrointestinal (bloating,
      abdominal pain, diarrhea and/or constipation, nausea, epigastric pain, gastroesophageal
      reflux, aphthous stomatitis) and very different extra-intestinal and systemic manifestations
      (headache, depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin rash,
      fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). Nowadays, there no
      data about a possible relationship between gynaecological disorders (i.e. menstrual cycle
      alterations, vaginitis, recurrent vulvovaginitis, recurrent cystitis, chronic pelvic pain,
      recurrent pregnancy loss, infertility) and food ingestion and food allergy/intolerance.
      Therefore, the aims of the present study are to investigate 1) the prevalence and
      characteristics of gynaecological disorders in NCWS patients compared to CD and IBS controls,
      and 2) the modification of such disorders in NCWS patients after a gluten (wheat)-free diet.
    

Intervention name(s): Gluten free diet
Intervention type(s): Other
Intervention description(s): The investigators will evaluate the modification of gynaecological disorder after a gluten (wheat)-free diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Non-celiac Wheat Sensitivity; gynaecological disorders; gluten-free diet