Gynaecological Disorders in Not-celiac Wheat Sensitivity
Italy500 participantsStarted 2001-01-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. age ≥18 years and ≤65 years;
✓. 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;
✓. 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;
Exclusion criteria
✕. 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;
✕. self-elimination of wheat from the diet and refusal to reintroduce it for a diagnostic purpose, before entering in to the study;
✕. treatment with corticosteroids and non steroidal anti-inflammatory (FANS) drugs during the 2 weeks before the duodenal biopsies;
What they're measuring
1
Gynaecological disorders in NCWS female patients at baseline
✕. EMA positivity in the culture medium of duodenal biopsies (EMA biopsy), even with a normal villo/crypt ratio in the mucosa;
✕. pregnancy or breastfeeding;
✕. alcohol and/or drug abuse;
✕. chronic inflammatory bowel disease or other intestinal organic disease; nervous system disease or major psychiatric disorders; infectious diseases; immunological deficits and physical impairments; 7) diagnosis of uro-gynecological organic diseases (uro-genital infections, endometriosis, neoplasms, etc.), confirmed by an uro-gynecologist both before the diagnosis of NCWS and during the follow-up period.