Ignite Creation Date:
2024-05-06 @ 9:37 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03027492
Status:
COMPLETED
Last Update Posted:
2021-09-28
First Post:
2016-12-30
Brief Title:
Gynaecological Disorders in Not-celiac Wheat Sensitivity
Sponsor:
University of Palermo
Organization:
University of Palermo
Study Overview
Official Title:
Gynaecological Disorders in Patients With Not-celiac Wheat Sensitivity
Status:
COMPLETED
Status Verified Date:
2021-09
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:
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 andor 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 andor 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 jointmuscle pain leg or arm numbness and anemia Nowadays there no data about a possible relationship between gynaecological disorders and food ingestion and food allergyintolerance 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
Detailed 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 andor 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 DQ2DQ8 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 andor 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 jointmuscle pain leg or arm numbness and anemia Nowadays there no data about a possible relationship between gynaecological disorders ie menstrual cycle alterations vaginitis recurrent vulvovaginitis recurrent cystitis chronic pelvic pain recurrent pregnancy loss infertility and food ingestion and food allergyintolerance 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 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