Clinical Trials Logo

Clinical Trial 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 CD and irritable bowel syndrome (IBS) controls, and 2) the modification of such disorders in NCWS patients after a gluten (wheat)-free diet.


Clinical Trial 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 CD and IBS controls, and 2) the modification of such disorders in NCWS patients after a gluten (wheat)-free diet. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03027492
Study type Interventional
Source University of Palermo
Contact
Status Completed
Phase N/A
Start date January 1, 2001
Completion date July 31, 2021

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 NCT03022994 - Duodenal and Rectal Histology in Non-celiac Wheat Sensitivity and Irritable Bowel Syndrome Patients 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 NCT03008252 - Lactose Intolerance and Cow's Milk Protein Allergy in Non-celiac Wheat Sensitivity Patients
Completed NCT04154137 - Self-reported Non-celiac Wheat Sensitivity (NCWS) in Patients Undergoing Digestive Endoscopy
Completed NCT04077840 - Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients