Ignite Creation Date:
2024-05-06 @ 9:31 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03008252
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2016-12-29
Brief Title:
Lactose Intolerance and Cows Milk Protein Allergy in Non-celiac Wheat Sensitivity Patients
Sponsor:
University of Palermo
Organization:
University of Palermo
Study Overview
Official Title:
Lactose Intolerance and Cows Milk Protein Allergy in Non-celiac Wheat Sensitivity Patients
Status:
COMPLETED
Status Verified Date:
2020-10
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 researchers 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 extra-intestinal or systemic manifestations headache depression anxiety foggy mind tiredness dermatitis or skin rash fibromyalgia-like jointmuscle pain leg or arm numbness and anemia Lactose intolerance and cows milk protein allergy CMPA are two medical conditions with a very high prevalence in the general population and there is a large overlap between NCWS symptoms and lactose intolerance and CMPA symptoms Therefore the aims of the present study are to investigate 1 the prevalence of positive lactose breath test and DBPC cows milk protein challenge in NCWS patients with self-reported gastrointestinal symptoms related to milk andor milk derivates ingestion 2 the clinical serological and histological characteristics of NCWS patients with lactose intolerance and CMPA in comparison to NCWS patients without lactose intolerance and CMPA
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 celiac disease CD or wheat allergy This clinical condition has been named non-celiac gluten sensitivity NCGS although in a recent article the researchers 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 researchers 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 irritable bowel syndrome 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 extra-intestinal or systemic manifestations headache depression anxiety foggy mind tiredness dermatitis or skin rash fibromyalgia-like jointmuscle pain leg or arm numbness and anemia Lactose intolerance and cows milk protein allergy CMPA are two conditions with a very high prevalence in the general population and there is a large overlap between NCWS and lactose intolerance and CMPA symptoms Therefore the aims of the present study are to investigate 1 the prevalence of positive lactose breath test and DBPC cows milk protein challenge in NCWS patients with self-reported gastrointestinal and extra-intestinal symptoms related to milk andor milk derivates ingestion 2 the clinical serological and histological characteristics of NCWS patients with lactose intolerance and CMPA in comparison to NCWS patients without lactose intolerance and CMPA
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