Osteoporosis In Non-Celiac Wheat Sensitivity Patients

Status Completed

Clinical Trial Summary

Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the spectrum of gluten-related disorders. No data are available on the prevalence of low bone mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS patients and search for correlations with other clinical characteristics.

This prospective observation study will include 90 NCWS patients with irritable bowel syndrome (IBS)-like symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine and at the Gastroenterology Units of the University of Palermo. Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent BMD assessment by Dual Energy X-Ray Absorptiometry (DXA), duodenal histology, Human Leukocyte Antigen (HLA) DQ typing, body mass index (BMI) evaluation and assessment for daily calcium intake.

Clinical Trial Description

Celiac disease (CD) has been reported to increase the risk of osteoporosis, with a resulting augmented risk of fractures. More recently, it has been reported that a consistent percentage of the general population consider themselves to be suffering from problems caused by wheat and/or 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. That previous study also showed a percentage of NCWS patients had weight loss and anemia: whether these depended on the intestinal malabsorption or not remains unclear. As yet no data are available on the presence and prevalence of low bone mass density (BMD) in NCWS patients. The aims of the present study is: 1) to investigate the prevalence of low BMD in NCWS patient and 2) to search for a possible correlation between BMD and other clinical characteristics, in particular the body mass index (BMI), of NCWS patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02421783
Study type	Observational
Source	University of Palermo
Contact
Status	Completed
Phase
Start date	May 1, 2015
Completion date	June 1, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05469971` - KIR Genes and Non-Celiac Wheat Sensitivity
Completed	`NCT02421796` - Malnutrition In Non-Celiac Wheat Sensitivity Patients
Completed	`NCT02421809` - Oral Lesions In Non-Celiac Wheat Sensitivity Patients
Completed	`NCT03022513` - Fibromyalgia-like Joint/Muscle Pain and Synovitis in Non-celiac Wheat Sensitivity Patients	N/A
Completed	`NCT02823522` - Non-Celiac Wheat Sensitivity: Permanent or Transient Condition?	N/A
Completed	`NCT02248545` - Autoimmune Diseases And Serum Anti-Nuclear Antibodies Positivity In Non-Celiac Wheat Sensitivity Patients	N/A
Completed	`NCT03022994` - Duodenal and Rectal Histology in Non-celiac Wheat Sensitivity and Irritable Bowel Syndrome Patients	N/A
Completed	`NCT03021148` - Self-reported Gluten Sensitivity in High-school Students	N/A
Completed	`NCT03017274` - Abdominal Ultrasound Examination in Non-celiac Wheat Sensitivity	N/A
Recruiting	`NCT03024775` - Response to Different Wheat Genotypes in Not-celiac Wheat Sensitivity	N/A
Completed	`NCT03008252` - Lactose Intolerance and Cow's Milk Protein Allergy in Non-celiac Wheat Sensitivity Patients
Completed	`NCT04154137` - Self-reported Non-celiac Wheat Sensitivity (NCWS) in Patients Undergoing Digestive Endoscopy
Completed	`NCT04077840` - Autoimmune Diseases and Serum Autoantibodies in NCWS and IBS Patients
Completed	`NCT03027492` - Gynaecological Disorders in Not-celiac Wheat Sensitivity	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.