The clinical charts of NCWS patients, diagnosed by DBPC gluten/wheat challenge, between January 2001 and December 2019, attending the Department of Internal Medicine at the University Hospital of Palermo, the Department of Internal Medicine of the Hospital of Sciacca, and the Department of Medical and Surgical Sciences of the University of Bologna, will be reviewed retrospectively. The investigators prospectively will also survey patients with functional gastroenterological symptoms according to the Rome III criteria, and a definitive diagnosis of NCWS by DBPC gluten/wheat challenge. The patients will be recruited between January 2019 and January 2022 at the same centers, and at the Internal Medicine Division of the "Cervello-Villa Sofia" Hospital of Palermo, Palermo.

To compare the presence and characteristics of anemia in NCWS patients, the clinical charts of a control group of CD patients had been randomly chosen by a computer-generated method from patients diagnosed in the same centers, during the same period (2001-2019), and age- and sex-matched with the NCWS patients. The investigators prospectively will also survey a control group of CD patients randomly chosen by a computer-generated method from subjects diagnosed in the same centers, during the same period (2019-2022), and age- and sex-matched with the NCWS patients.

To compare the presence and characteristics of anemia in NCWS patients, the clinical charts of another control group of IBS patients had been randomly chosen by a computer-generated method from patients diagnosed in the same centers, during the same period (2001-2019), and age- and sex-matched with the NCWS patients. The investigators prospectively will also survey a control group of IBS patients randomly chosen by a computer-generated method from subjects diagnosed in the same centers, during the same period (2019-2022), and age- and sex-matched with the NCWS patients.

Non-celiac Gluten Sensitivity

Anemia

Evaluation of anemia in NCWS patients, and in CD and IBS controls, with both retrospective and prospective method.

Evaluation of anemia

Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca

Internal Medicine Division of the "Cervello-Villa Sofia" Hospital

Department of Internal Medicine, University Hospital of Palermo

Anemia in Non-celiac Wheat Sensitivity

Clinical Characteristics and Pathogenic Mechanisms of Anemia in Non-celiac Wheat Sensitivity Compared to Celiac Disease and Irritable Bowel Syndrome

red blood cells (adults references ranges, RR, 4.5-5.9 million cells/mcL, men, 4.1-5.1 million cells/mcL, women), hemoglobin (RR 13-17 g/dL, men, 12-15 g/dL, women), hematocrit (RR 40%-52%, men, 36%-47%, women), mean corpuscular volume (RR 80-100 fL), mean corpuscular hemoglobin (RR 0.4-0.5 fmol/cell), mean corpuscular hemoglobin concentration (RR 30-35 g/dL), red cell distribution width (RR 11.5%-14.5%)

reticulocytes count (RR 0.5%-1.5%), total serum iron (RR 65-180 µg/dL, men, 30-170 µg/dL, women), ferritin (RR 12-300 ng/mL, men, 12-150 ng/mL, women), transferrin (200-350 mg/dL), total iron-binding capacity (RR 45-85 µmol/L), vitamin B12 (RR 130-700 ng/L), folic acid (RR 7-36 nmol/L), thyroid-stimulating hormone (TSH, RR 2-10 μU/mL), anti-nuclear antibodies (ANA), anti-intrinsic factor (IFA) and/or parietal cell (APCA) antibodies

Pasquale Mansueto

Principal Investigator

University of Palermo

Adult patients with a definitive diagnosis of NCWS, based on DBPC wheat challenge, most of them suffering from IBS-like-clinical presentation, according to Rome IV criteria. The patients were consecutively recruited between January 2016 and October 2017 at the outpatient clinics of the Department of Internal Medicine of the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca (both in southern Italy)

Consecutive healthy blood donors sex- (+ 5%) and age-matched (+ 2 years) with the NCWS patients.

Consecutive patients with a diagnosis of IBS unrelated to NCWS or other types of food "intolerance/allergy", who were consecutively recruited during the study period and sex- (+ 5%) and age-matched (+ 2 years) with the NCWS patients.

Non-celiac Wheat Sensitivity

Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients

Autoimmune Diseases and Serum Autoantibodies in Non-celiac Wheat Sensitivity Patients in Comparison to IBS Patients

The presence of autoimmune disorders both in NCWS and IBS control patients was evaluated by a structured questionnaire and a review of patients' clinical records. The presence of one of the following was looked for in all subjects: connective tissue diseases, autoimmune endocrinological diseases, autoimmune hepatitis, primary biliary cirrhosis, epilepsy with cerebral calcification, unexplained cerebellar ataxia, alopecia, psoriasis, atrophic autoimmune gastritis, and immune anemia, neutropenia, or thrombocytopenia.

The frequency, titers and patterns of serum ANA, antibodies against double stranded DNA (anti-dsDNA), extractable nuclear antigen (ENA), islet cells of the pancreas (ICA), parietal cell antibodies (APCA), and, finally, tireoglobulin (anti-TG) and thyroid peroxidase (anti-TPO) were evaluated by ELISA and Immunofluorescence.

Frequency of autoimmune diseases and autoantibodies were correlated with the following clinical and laboratory parameters: age at diagnosis, gender, coexistent pathologies, atopic diseases and nickel allergy, anemia, coexistent other food allergies, presence of IBS-like symptoms, functional dyspepsia, and extraintestinal symptoms, BMI, duodenal histology lesions, and DQ2/DQ8 HLA haplotypes.

Clinical Professor

Seventy subjects with nonceliac gluten sensitivity will be given 14 gastrosoluble capsules containing purified wheat gluten corresponding to a daily gluten intake of 8.4 grams for five days. At the end of the first five day-long treatment, subjects will continue only their wash-out from gluten for two weeks, without taking any capsule. At T3, individuals will be given 14 daily gastrosoluble capsules containing placebo (rice starch) for five days. In both first and second five day-long treatment the 14 capsules will be ingested in no more than two times using a glass of water over the day.

Seventy subjects with nonceliac gluten sensitivity will be given 10 gastrosoluble capsules containing purified wheat gluten corresponding to a daily gluten intake of 6.0 grams for five days. In order to maintain the double-blind, patients will be also given 4 capsules of placebo (rice starch) per day. At the end of the first five day-long treatment, subjects will continue only their wash-out from gluten for two weeks, without taking any capsule. At T3, individuals will be given 14 daily gastrosoluble capsules containing placebo (rice starch) for five days. In both first and second five day-long treatment the 14 capsules will be ingested in no more than two times using a glass of water over the day.

Seventy subjects with nonceliac gluten sensitivity will be given 7 gastrosoluble capsules containing purified wheat gluten corresponding to a daily gluten intake of 4.2 grams for five days. In order to maintain the double-blind, patients will be also given 7 capsules of placebo (rice starch) per day. At the end of the first five day-long treatment, subjects will continue only their wash-out from gluten for two weeks, without taking any capsule. At T3, individuals will be given 14 daily gastrosoluble capsules containing placebo (rice starch) for five days. In both first and second five day-long treatment the 14 capsules will be ingested in no more than two times using a glass of water over the day.

Seventy subjects with nonceliac gluten sensitivity will be given 14 daily gastrosoluble capsules containing placebo (rice starch) for five days. At the end of the first five day-long treatment, subjects will continue only their wash-out from gluten for two weeks, without taking any capsule. At T3, individuals will be given 7 daily gastrosoluble capsules containing purified wheat gluten corresponding to a daily gluten intake of 4.2 grams for five days. In order to maintain the double-blind, patients will be also given 7 capsules of placebo (rice starch) per day. In both first and second five day-long treatment the 14 capsules will be ingested in no more than two times using a glass of water over the day.

Seventy subjects with nonceliac gluten sensitivity will be given 14 daily gastrosoluble capsules containing placebo (rice starch) for five days. At the end of the first five day-long treatment, subjects will continue only their wash-out from gluten for two weeks, without taking any capsule. At T3, individuals will be given 10 daily gastrosoluble capsules containing purified wheat gluten corresponding to a daily gluten intake of 6.0 grams for five days. In order to maintain the double-blind, patients will be also given 4 capsules of placebo (rice starch) per day. In both first and second five day-long treatment the 14 capsules will be ingested in no more than two times using a glass of water over the day.

Seventy subjects with nonceliac gluten sensitivity will be given 14 daily gastrosoluble capsules containing placebo (rice starch) for five days. At the end of the first five day-long treatment, subjects will continue only their wash-out from gluten for two weeks, without taking any capsule. At T3, individuals will be given 14 daily gastrosoluble capsules containing purified wheat gluten corresponding to a daily gluten intake of 8.4 grams for five days. In both first and second five day-long treatment the 14 capsules will be ingested in no more than two times using a glass of water over the day.

Seventy healthy volunteers will be given 14 gastrosoluble capsules containing purified wheat gluten corresponding to a daily gluten intake of 8.4 grams for five days. At the end of the first five day-long treatment, subjects will continue only their wash-out from gluten for two weeks, without taking any capsule. At T3, individuals will be given 14 daily gastrosoluble capsules containing placebo (rice starch) for five days. In both first and second five day-long treatment the 14 capsules will be ingested in no more than two times using a glass of water over the day.

Seventy healthy volunteers will be given 10 gastrosoluble capsules containing purified wheat gluten corresponding to a daily gluten intake of 6.0 grams for five days. In order to maintain the double-blind, patients will be also given 4 capsules of placebo (rice starch) per day. At the end of the first five day-long treatment, subjects will continue only their wash-out from gluten for two weeks, without taking any capsule. At T3, individuals will be given 14 daily gastrosoluble capsules containing placebo (rice starch) for five days. In both first and second five day-long treatment the 14 capsules will be ingested in no more than two times using a glass of water over the day.

Seventy healthy volunteers will be given 7 gastrosoluble capsules containing purified wheat gluten corresponding to a daily gluten intake of 4.2 grams for five days. In order to maintain the double-blind, patients will be also given 7 capsules of placebo (rice starch) per day. At the end of the first five day-long treatment, subjects will continue only their wash-out from gluten for two weeks, without taking any capsule. At T3, individuals will be given 14 daily gastrosoluble capsules containing placebo (rice starch) for five days. In both first and second five day-long treatment the 14 capsules will be ingested in no more than two times using a glass of water over the day.

Seventy healthy volunteers will be given 14 daily gastrosoluble capsules containing placebo (rice starch) for five days. At the end of the first five day-long treatment, subjects will continue only their wash-out from gluten for two weeks, without taking any capsule. At T3, individuals will be given 7 daily gastrosoluble capsules containing purified wheat gluten corresponding to a daily gluten intake of 4.2 grams for five days. In order to maintain the double-blind, patients will be also given 7 capsules of placebo (rice starch) per day. In both first and second five day-long treatment the 14 capsules will be ingested in no more than two times using a glass of water over the day.

Seventy healthy volunteers will be given 14 daily gastrosoluble capsules containing placebo (rice starch) for five days. At the end of the first five day-long treatment, subjects will continue only their wash-out from gluten for two weeks, without taking any capsule. At T3, individuals will be given 14 daily gastrosoluble capsules containing purified wheat gluten corresponding to a daily gluten intake of 8.4 grams for five days. In both first and second five day-long treatment the 14 capsules will be ingested in no more than two times using a glass of water over the day.

Nonceliac Gluten Sensitivity

Administration of gluten or placebo capsules

Gluten or placebo capsules

Fondazione IRCCS Policlinico San Matteo

Dose-finding Gluten Challenge Trial in Nonceliac Gluten-sensitivity

Randomized, Dose-finding, Double-blind, Placebo-controlled, Crossover Gluten Challenge Trial in Subjects With Nonceliac Gluten-sensitivity

The change in delta overall (intestinal plus extraintestinal) score, calculated by subtracting the 5-day overall score under placebo from the 5-day overall score under gluten, between the highest daily intake of gluten (8.4 grams) and the lowest ones (either 6.0 or 4.2 grams) in nonceliac gluten sensitivity.

True nonceliac gluten-sensitive patients will be defined as having at the end of the trial a delta overall score higher than the mean delta overall score plus two standard deviations of healthy volunteers taking the same daily gluten dose.

To verify whether laboratory parameters (erum IgG AGA, HLA genotyping and intraepithelial lymphocyte density) at baseline might be predictive of true nonceliac gluten sensitivity

Antonio Di Sabatino

Associate Professor

Randomized, dose-finding, double-blind, placebo-controlled, crossover gluten challenge trial

We prospectively will survey 30 nuns from the "Congregazione delle Suore Collegine della Santa Famiglia", Palermo, Italy. The subjects will be recruited between January 2017 and June 2017 and will be examined before and after the diet period (30 days) with ancient grains, undergoing clinical evaluation and blood and feces samples collection. Ancient wheat flours will be administered in open label for 30 days

Gluten Sensitivity

Ancient wheat flours will be administered in open label for 30 days

Ancient wheat flours

Congregazione delle Suore Collegine della Santa Famiglia

Effects of Ancient Grains-based Diet in a Closed Community

Laboratory Values evaluation at baseline and after a 30 days challenge with ancient grains-based diet.

Evaluation of modifications of intestinal microbiota (bacterial flora) by feces samples examination, before and after a 30 days challenge with ancient grains-based diet.

Evaluation of modifications in cytokines production from PBMC, before and after the diet period (30 days) with ancient grains.

disaccharide/bolest hlavy

Anemia in Non-celiac Wheat Sensitivity

Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients

Dose-finding Gluten Challenge Trial in Nonceliac Gluten-sensitivity

Effects of Ancient Grains-based Diet in a Closed Community

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