Ignite Creation Date:
2024-05-06 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03022513
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2016-12-30
Brief Title:
Fibromyalgia-like JointMuscle Pain and Synovitis in Non-celiac Wheat Sensitivity Patients
Sponsor:
University of Palermo
Organization:
University of Palermo
Study Overview
Official Title:
Fibromyalgia-like JointMuscle Pain and Synovitis in Non-celiac Wheat Sensitivity Patients
Status:
COMPLETED
Status Verified Date:
2020-04
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 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 no data are available on the characteristic of rheumatologic symptoms of NCWS patients Therefore the aims of the present study are 1 to investigate the prevalence of fibromyalgia-like jointmuscle pain in NCWS patient 2 to search for possible ultrasonographic alterations ie synovitis of hands and feet joints of NCWS patients and 3 to evaluate modification of fibromyalgia-like jointmuscle pain in NCWS patients after a gluten free diet period of almost 6 months
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 CD is an immunological disorder whose best-known manifestations are gastrointestinal symptoms However early joint manifestations are common and frequently overlooked features of the disease Similarly 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 no data are available on the characteristic of rheumatological symptoms of NCWS patients Therefore the aims of the present study are 1 to investigate the prevalence of fibromyalgia-like jointmuscle pain in NCWS patient 2 to search for possible ultrasonographical alterations ie synovitis of hands and feet joints of NCWS patients and 3 to evaluate modification of fibromyalgia-like jointmuscle pain in NCWS patients after a gluten free diet period of almost 6 months
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