Non-celiac Wheat Sensitivity
Conditions
Keywords
Non-celiac Wheat Sensitivity, gynaecological disorders, gluten-free diet, celiac disease, irritable bowel syndrome
Brief 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 healthy, CD and irritable bowel syndrome (IBS) controls, 2) the modification of such disorders in NCWS patients after a gluten (wheat)-free diet, and 3) whether cytological alterations could be identified on samples taken during Papanicolaou (PAP) tests performed in NCWS patients with uro-gynecological disorders on strict WFD and after a 7-day open challenge with wheat.
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 healthy, CD and IBS controls, 2) the modification of such disorders in NCWS patients after a gluten (wheat)-free diet, and 3) whether cytological alterations could be identified on samples taken during Papanicolaou (PAP) tests performed in NCWS patients with uro-gynecological disorders on strict WFD and after a 7-day open challenge with wheat.
Interventions
OTHERGluten free diet
The investigators will evaluate the modification of gynaecological disorder after a gluten (wheat)-free diet.
OTHERNCWS open challenge with wheat
In a small group of NCWS patients a cervical-vaginal PAP test was performed during 'strict' WFD and then repeated after a single 7-day open challenge with wheat (patients were invited to continue their strict WFD adding 80g/die of Triticum aestivum flour which should be cooked and eaten as semolina).
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
To diagnose NCWS the recently proposed criteria will be adopted. All the patients will meet the following criteria: 1. age ≥18 years and ≤65 years; 2. negative serum assays for celiac disease: anti-deamidated gliadin peptide (anti-DGP) Ig (Immunoglobulin)A and IgG antibodies, anti-tissue transglutaminase (anti-tTG) IgA and IgG antibodies, and anti-endomysium (anti-EMA) IgA antibodies; 3. absence of duodenal villous atrophy, documented in all the patients carrying the DQ2 and/or DQ8 Human Leukocyte Antigens (HLA) haplotypes, evaluated during the ingestion of at least 100g of bread and/or pasta every day for at least 45 days; 4. exclusion of IgE-mediated wheat allergy, documented by a negative skin prick-test and/or serum dosage of IgE specific for wheat, gluten and gliadin; 5. complete resolution of symptoms after a strict standard elimination diet (oligoantigenic diet, free of wheat, cow's milk, eggs, tomatoes, chocolate, and other foods self-reported by patient as cause of symptoms) continued for at least 4 weeks, followed by the recurrence of symptoms after double-blind placebo-controlled wheat challenge or open challenges for the others self-reported foods; 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gynaecological disorders in NCWS female patients at baseline | Up to 200 months | Prevalence of gynaecological disorders in retrospective and prospective NCWS female patients, compared to retrospective and prospective CD and IBS female patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gynaecological disorders in NCWS female patients after gluten-free diet. | Change from baseline to at leats 6 months of gluten-free diet | Gynaecological disorders evaluation after at least 6 months of gluten-free diet after the NCWS diagnosis, by visual analogic scales, specific questionnaire, and clinical examination, both in retrospective and prospective NCWS female patients. |
| PAP test in NCWS female patients after gluten-free diet. | Change from baseline at 6 months of gluten-free diet | PAP smear after at least 6 months of gluten-free diet after the NCWS diagnosis, both in retrospective and prospective NCWS female patients. |
| PAP test in NCWS female patients after 7-day open challenge with wheat. | After at least 6 months of gluten-free diet | In a small group of NCWS patients a cervical-vaginal PAP test was performed during 'strict' WFD and then repeated after a single 7-day open challenge with wheat (patients were invited to continue their strict WFD adding 80g/die of Triticum aestivum flour which should be cooked and eaten as semolina). |
Countries
Italy
Contacts
STUDY_DIRECTORAntonio Carroccio, MD
University of Palermo
Outcome results
None listed