• Overview
  • Eligibility
  • More info
  • Locations

Gynaecological Disorders in Patients With Not-celiac Wheat Sensitivity (NCT03027492)

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.
  • Other: Gluten free diet
    The investigators will evaluate the modification of gynaecological disorder after a gluten (wheat)-free diet.
    Ages eligible for Study
    15 Years to 65 Years
    Genders eligible for Study
    Female
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • To diagnose NCWS the recently proposed criteria will be adopted. All the patients will meet the following criteria:
    • negative serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies
    • absence of intestinal villous atrophy
    • negative IgE-mediated immune-allergy tests to wheat (skin prick tests and/or serum specific IgE detection)
    • resolution of the IBS symptoms on standard elimination diet, excluding wheat, cow's milk, egg, tomato, chocolate, and other self-reported food(s) causing symptoms
    • symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge. As the investigators previously described in other studies, DBPC cow's milk protein challenge and other "open" food challenges will be performed too. To diagnose CD the standard criteria will be adopted. All the patients will meet the following criteria:
    • positive serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies
    • presence of intestinal villous atrophy. To diagnose IBS the standard Rome II (for retrospective patients) and Rome III (for prospective patients) Criteria will be adopted. None of these subjects improved on an elimination diet without wheat, cow's milk, egg, tomato, or chocolate.
    Exclusion Criteria:
    • For NCWS diagnosis it will be evaluated the following exclusion criteria:
    • positive EmA in the culture medium of the duodenal biopsies, also in the case of normal villi/crypts ratio in the duodenal mucosa
    • self-exclusion of wheat from the diet and refusal to reintroduce it before entering the study
    • other previously diagnosed gastrointestinal disorders
    • other previously diagnosed gynaecological disorders
    • nervous system disease and/or major psychiatric disorder
    • physical impairment limiting physical activity.
    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.

    2 locations

    Italy (2)
    • Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca
      recruiting
      Sciacca, Agrigento, Italy, 92019
    • Department of Internal Medicine, University Hospital of Palermo
      recruiting
      Palermo, Italy, 90129
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    -
    Start:
    31 December, 2000
    Updated:
    16 January, 2017
    Participants:
    150
    Apply
    A girl giving information about available additional trials.

    FindMeCure helps you find, understand and join clinical trials from all over the world.

    There are more clinical trials for your condition!