Clinical Trials Logo

Clinical Trial Summary

Self-reported food hypersensitivity is common, particularly in women, with a reported prevalence of about 20% in the UK community. A wide range of gastrointestinal and systemic symptoms may be experienced related to consumption of the intolerant food(s). In addition, patients demonstrate considerably more generalized subjective health complaints in comparison with healthy controls. In this context, 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 celiac disease 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. In a previous study, the investigators demonstrated, in a population of teenagers, a frequency of self-reported NCWS of about 12%; the frequency of GFD use was 2.9%, which was much higher than the percentage of known CD in the same population (1.26%). The aims of this study were 1) to determine the prevalence of self-perceived wheat and/or gluten-sensitivity in patients undergoing digestive endoscopy, irrespective to the motivations of the test, and 2) to evaluate the demographic and clinical differences between patients self-reporting wheat and/or gluten sensitivity and patients not reporting food hypersensitivity.


Clinical Trial Description

Self-reported food hypersensitivity is common, particularly in women, with a reported prevalence of about 20% in the UK community. A wide range of gastrointestinal and systemic symptoms may be experienced related to consumption of the intolerant food(s). In addition, patients demonstrate considerably more generalized subjective health complaints in comparison with healthy controls. In this context, 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 celiac disease 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). To our knowledge, there are few studies which assessed the prevalence of self-reported wheat and/or gluten-related symptoms in the community and analyze diagnostic outcomes in those referred to secondary gastrointestinal care. In one of these, performed in UK, the authors shown that gluten-related symptoms are self-reported by 13% of the population, with 3.7% consuming a gluten-free diet, despite only 0.8% being aware that they have a formal diagnosis of celiac disease. In this study individuals self-reporting gluten-related symptoms were predominantly female, reported an association with IBS, and experienced both intestinal and extraintestinal symptoms on gluten ingestion. Of those patients presenting to the gastroenterology department, the majority do not have CD but NCWS. In another study, the investigators demonstrated, in a population of teenagers, a frequency of self-reported NCWS of about 12%; the frequency of GFD use was 2.9%, which was much higher than the percentage of known CD in the same population (1.26%). The aims of this study were 1) to determine the prevalence of self-perceived wheat and/or gluten-sensitivity in patients undergoing digestive endoscopy, irrespective to the motivations of the test, and 2) to evaluate the demographic and clinical differences between patients self-reporting wheat and/or gluten sensitivity and patients not reporting food hypersensitivity. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04154137
Study type Observational [Patient Registry]
Source University of Palermo
Contact
Status Completed
Phase
Start date January 1, 2017
Completion date January 1, 2020

See also
  Status Clinical Trial Phase
Completed NCT05469971 - KIR Genes and Non-Celiac Wheat Sensitivity
Completed NCT02421809 - Oral Lesions In Non-Celiac Wheat Sensitivity Patients
Completed NCT02421783 - Osteoporosis 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 NCT03022994 - Duodenal and Rectal Histology in Non-celiac Wheat Sensitivity and Irritable Bowel Syndrome 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 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