Clinical Trials Logo

Clinical Trial Summary

Recently it has been reported that a consistent percentage of the general population 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). In a previous paper the investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes the symptoms in NCGS patients, and the investigators also showed that these patients had a high frequency of coexistent multiple food hypersensitivity. Nowadays only few data are available on the histological characteristic of duodenal and rectal biopsies of NCWS patients. The researchers have just demonstrated a significant eosinophils infiltration of the duodenal and colon mucosa, and a significant infiltration of CD45+/CD3-CD14- cells in the rectal mucosa of NCWS patients upon wheat challenge, thus configuring a diffuse gastrointestinal "inflammatory/immunologic" pattern. The aims of the present study are: 1) to investigate the histological characteristics in duodenal and rectal biopsies between NCWS and irritable bowel syndrome (IBS) patients, and 2) to evaluate which site (i.e. duodenal or rectal) shows "inflammatory/allergic" features useful for NCWS histological diagnosis.


Clinical Trial Description

Recently it has been reported that a consistent percentage of the general population 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). In a previous paper the investigators suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what component of wheat causes the symptoms in NCGS patients, and the investigators also showed that these patients had a high frequency of coexistent multiple food hypersensitivity. 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 extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). Nowadays only few data are available on the histological characteristic of duodenal and rectal biopsies of NCWS patients. The researchers have just demonstrated a significant eosinophils infiltration of the duodenal and colon mucosa, and a significant infiltration of CD45+/CD3-CD14- cells in the rectal mucosa of NCWS patients upon wheat challenge, thus configuring a diffuse gastrointestinal "inflammatory/immunologic" pattern. As regard to rectal lymphocytes, analysis of cytokine production demonstrated dominant spontaneous interferon (IFN)-γ production by these cells, which were further identified as innate lymphoid cells belonging to the group 1 (ILC1) population, expressing T-bet and producing IFN-γ, compatible to an innate immunity involvement in NCWS pathogenesis. Therefore, the aims of the present study are: 1) to investigate the histological characteristics and differences in duodenal and rectal biopsies between NCWS and IBS patients, and 2) to search for "inflammatory/allergic" features (i.e. eosinophils and/or lymphocytes infiltration) useful for NCWS histological diagnosis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03022994
Study type Observational
Source University of Palermo
Contact
Status Completed
Phase N/A
Start date January 2016
Completion date July 2017

See also
  Status Clinical Trial Phase
Completed NCT05469971 - KIR Genes and Non-Celiac Wheat Sensitivity
Completed NCT02421783 - Osteoporosis In Non-Celiac Wheat Sensitivity Patients
Completed NCT02421809 - Oral Lesions In Non-Celiac Wheat Sensitivity Patients
Completed NCT02421796 - Malnutrition In Non-Celiac Wheat Sensitivity Patients
Completed NCT03022513 - Fibromyalgia-like Joint/Muscle Pain and Synovitis in Non-celiac Wheat Sensitivity Patients N/A
Completed NCT02823522 - Non-Celiac Wheat Sensitivity: Permanent or Transient Condition? N/A
Completed NCT02248545 - Autoimmune Diseases And Serum Anti-Nuclear Antibodies Positivity In Non-Celiac Wheat Sensitivity Patients N/A
Completed NCT03021148 - Self-reported Gluten Sensitivity in High-school Students N/A
Completed NCT03017274 - Abdominal Ultrasound Examination in Non-celiac Wheat Sensitivity N/A
Recruiting NCT03024775 - Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity N/A
Completed NCT04154137 - Self-reported Non-celiac Wheat Sensitivity (NCWS) in Patients Undergoing Digestive Endoscopy
Completed NCT03008252 - Lactose Intolerance and Cow's Milk Protein Allergy in Non-celiac Wheat Sensitivity Patients
Completed NCT04077840 - Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients
Completed NCT03027492 - Gynaecological Disorders in Not-celiac Wheat Sensitivity N/A