Could wheat be messing with Women's health? new study investigates

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 exclusion criteria: 1. self-elimination of wheat from the diet and refusal to reintroduce it for a diagnostic purpose, before entering in to the study; 2. treatment with corticosteroids and non steroidal anti-inflammatory (FANS) drugs during the 2 weeks before the duodenal biopsies; 3. EMA positivity in the culture medium of duodenal biopsies (EMA biopsy), even with a normal villo/crypt ratio in the mucosa; 4. pregnancy or breastfeeding; 5. alcohol and/or drug abuse; 6. 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. Additional specific inclusion/exclusion criteria for NCWS patients were used in this study: 1) female patient complaining of uro-gynecological disorders; 2) at least one uro-gynecological visit, including an uro-gynecological ultrasound and microbiological tests, that excluded uro-gynecological organic diseases within 6 months before the recruitment in the study; 3) follow-up period of at least 12 months after the initial diagnosis of NCWS and at least 2 outpatient, every 6 months, visits during the follow-up; 4) strict adherence to WFD 12 months after NCWS diagnosis. Healthy controls had to respect the following inclusion criteria: 1) female gender; 2) age ≥18 years and ≤65 years; 3) negative serology for anti- Deamidated Gliadin Peptide (DGP) IgA and IgG antibodies, anti-tissue TransGlutaminase (tTG) IgA and IgG antibodies; 4) absence of self-reported symptoms related to wheat intake; 5) at least one uro-gynecological visit, including an uro-gynecological ultrasound and microbiological tests, that excluded uro-gynecological organic diseases within 6 months before the recruitment in the study. Additional exclusion criteria for both NCWS patients and healthy controls were: 1) use of drugs potentially causes of the uro-gynecological disorders; 2) diagnosis of uro-gynecological organic diseases (uro-genital infections, endometriosis, neoplasms, etc.), confirmed by an uro-gynecologist; 3) previous surgical interventions on the uro-genital system; 4) absence of signed informed consent form.