Gynaecological Disorders in Not-celiac Wheat Sensitivity
NCT03027492
Celiac Disease, Colonic Diseases
Sciacca, Agrigento, Italy
View Trial DetailsNCT Number: NCT02421796
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 malnutrition 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 nutritional parameters measurement, duodenal histology, Human Leucocyte Antigen (HLA) DQ typing and body mass index (BMI) evaluation.
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Notify Me18 year–65 year
All sexes
Observational
Antonio Carroccio, Sciacca, Agrigento, Italy
Celiac disease (CD) has been reported to increase the risk of malnutrition due to malabsorption. 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 malnutrition in NCWS patient and 2) to search for a possible correlation with other clinical characteristics, in particular the body mass index (BMI), of NCWS patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
To diagnose NCWS the recently proposed criteria will be adopted. All the patients will meet the following criteria:
Additional inclusion criteria will be:
Exclusion criteria
Time frame: At baseline and at 24 months
The BMI [weight (kg) to the square of the height (m2)]. According to the World Health Organization, patients will be categorized as underweight (BMI <18.5), normal BMI 18.5 to 24.9, overweight BMI 25 to 29.9 and obese 30 to 39.9, and extreme obesity >40.
Time frame: At baseline and at 24 months
Triceps skinfold measurement, using tricipital skinfold together with arm circumference, will be recorded as index of lean mass. The investigators will use the standard formula: AMC (Arm Muscle Circumference, mm) = UAC (Upper Arm Circumference, mm) - π (3.14) x TSF (Triceps Skinfold, mm).
Time frame: At baseline and at 24 months
Biometric impedance analysis will be performed to estimate total body water, extracellular water, fat-free mass and body cell mass.
Time frame: At baseline and at 24 months
Serum albumin levels will be assayed (references values 3.4-5.4 g/dL).
Time frame: At baseline and at 24 months
Serum transferrin levels will be assayed (references values 200-360 mg/dL).
Time frame: At baseline and at 24 months
Total serum cholesterol levels will be assayed (references values <200 mg/dL).
University of Palermo
Other
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