Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04769180
Status:
COMPLETED
Last Update Posted:
2021-02-24
First Post:
2021-02-20
Brief Title:
Extraintestinal Non Celiac Wheat Sensitivity
Sponsor:
University of Palermo
Organization:
University of Palermo
Study Overview
Official Title:
Extraintestinal Manifestations in Non Celiac Wheat Sensitivity
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Non Celiac Gluten Sensitivity NCGS or better Non Celiac Wheat Sensitivity NCWS since it is not known the real pathogenetic components of grain is a syndrome characterized by a cohort of symptoms both gastrointestinal and extraintestinal related to the ingestion of glutenwheat-containing food in subjects who are not affected by celiac disease CD or wheat allergy In particular the possibility of extraintestinal manifestations in this condition has been suggested by some reports In most cases they are characterized by vague symptoms such as headache foggy mind fatigue joint and muscle pain leg or arm numbness ie fibromyalgia-like symptoms even if more specific complaints have been described A possible neurological involvement has been underlined by NCWS association with gluten encephalopathy gluten ataxia and gluten peripheric neuropathy NCWS patients may show even psychiatric diseases such as anxiety depression and psychosis Other described extraintestinal manifestations are dermatitis eczema or skin rash gynecological disorders and anemia In addition the association of NCWS with autoimmune diseases such as autoimmune thyroiditis and presence of anti-nuclear or other autoantibodies has been demonstrated suggesting that similarly to CD NCWS might be considered as an immune system-related disease and this aspect should be of relevance In conclusion the novelty of this matter has generated an expansion of literature data about the clinical features of the disease with the unavoidable consequence that some reports are often based on low levels of evidence The aims of the present study were to a retrospectively evaluate the prevalence and kind of extraintestinal symptoms in a large cohort of NCWS patients b to research for a possible relationship between the clinical serological genetic and histological characteristics of the NCWS patients and the number and kind of extraintestinal manifestations As control groups the researchers used CD and Irritable Bowel Syndrome IBS patients unrelated to NCWS or other food allergiesintolerances
Detailed Description:
Non Celiac Gluten Sensitivity NCGS or better Non Celiac Wheat Sensitivity NCWS since it is not known the real pathogenetic components of grain is a syndrome characterized by a cohort of symptoms both gastrointestinal and extraintestinal related to the ingestion of glutenwheat-containing food in subjects who are not affected by celiac disease CD or wheat allergy In detail NCWS is distinguished by symptoms that typically take place soon after glutenwheat ingestion withdraw with glutenwheat exclusion and relapse following glutenwheat challenge ie double-blinded placebo-controlled DBPC glutenwheat challenge used for diagnostic purpose within hours or days The gastrointestinal clinical picture of NCWS is a combination of irritable bowel syndrome IBS-like manifestations such as abdominal pain bloating diarrhea or constipation or alternation of diarrhea and constipation and dyspepsia like-symptoms such as postprandial heaviness early satiety and epigastric pain or burning However the possibility of extraintestinal manifestations in this condition has been suggested by some reports In most cases they are characterized by vague symptoms such as headache foggy mind fatigue joint and muscle pain leg or arm numbness ie fibromyalgia-like symptoms even if more specific complaints have been described A possible neurological involvement has been underlined by NCWS association with gluten encephalopathy gluten ataxia and gluten peripheric neuropathy NCWS patients may show even psychiatric diseases such as anxiety depression and psychosis Other described extraintestinal manifestations are dermatitis eczema or skin rash gynecological disorders and anemia In addition the association of NCWS with autoimmune diseases such as autoimmune thyroiditis and presence of anti-nuclear or other autoantibodies has been demonstrated suggesting that similarly to CD NCWS might be considered as an immune system-related disease and this aspect should be of relevance In conclusion the novelty of this matter has generated an expansion of literature data about the clinical features of the disease with the unavoidable consequence that some reports are often based on low levels of evidence Therefore only studies performed on large samples with the inclusion of control groups may be able to clearly establish whether the large information from the literature regarding extraintestinal NCWS manifestations could be supported by evidence-based agreements Therefore the aims of the present study were to a retrospectively evaluate the prevalence and kind of extraintestinal symptoms in a large cohort of NCWS patients diagnosed by DBPC glutenwheat challenge b to research for a possible relationship between the clinical serological genetic and histological characteristics of the NCWS patients and the number and kind of extraintestinal manifestations As control groups the researchers used CD and IBS patients unrelated to NCWS or other food allergiesintolerances
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None