Ignite Creation Date:
2024-05-06 @ 9:37 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03022994
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
2016-12-30
Brief Title:
Duodenal and Rectal Histology in Non-celiac Wheat Sensitivity and Irritable Bowel Syndrome Patients
Sponsor:
University of Palermo
Organization:
University of Palermo
Study Overview
Official Title:
Duodenal and Rectal Histology in Non-celiac Wheat Sensitivity and Irritable Bowel Syndrome Patients
Status:
COMPLETED
Status Verified Date:
2017-07
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:
Recently it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat andor 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 CD45CD3-CD14- cells in the rectal mucosa of NCWS patients upon wheat challenge thus configuring a diffuse gastrointestinal inflammatoryimmunologic 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 ie duodenal or rectal shows inflammatoryallergic features useful for NCWS histological diagnosis
Detailed Description:
Recently it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat andor 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 andor constipation nausea epigastric pain gastroesophageal reflux aphthous stomatitis and extra-intestinal andor systemic manifestations headache depression anxiety foggy mind tiredness dermatitis or skin rash fibromyalgia-like jointmuscle 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 CD45CD3-CD14- cells in the rectal mucosa of NCWS patients upon wheat challenge thus configuring a diffuse gastrointestinal inflammatoryimmunologic 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 inflammatoryallergic features ie eosinophils andor lymphocytes infiltration useful for NCWS histological diagnosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None