Malnutrition In Non-Celiac Wheat Sensitivity Patients

Sponsor

University of Palermo (Other)

Overall Status

Completed

CT.gov ID

NCT02421796

Collaborator

(none)

270

Enrollment

Locations

Actual Duration (Months)

135

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Non-Celiac Wheat Sensitivity

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

270 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Malnutrition In Non-Celiac Wheat Sensitivity Patients

Actual Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
NCWS patients Consecutive adult patients with an irritable bowel syndrome (IBS)-like clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS.
CD patients Sex- and age-matched subjects with CD, diagnosed according to standard criteria during the same study period and enrolled as first control group.
IBS patients Sex- and age-matched subjects with IBS unrelated to NCWS or other food 'intolerance', diagnosed according to standard criteria during the same study period and enrolled as second control group.

Outcome Measures

Primary Outcome Measures

Change in body mass index (BMI) [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.

Secondary Outcome Measures

Change in triceps skinfold thicknesses [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).
Change in biometric impedance [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.
Change in serum albumin [At baseline and at 24 months]
Serum albumin levels will be assayed (references values 3.4-5.4 g/dL).
Change in serum transferrin [At baseline and at 24 months]
Serum transferrin levels will be assayed (references values 200-360 mg/dL).
Change in total serum cholesterol [At baseline and at 24 months]
Total serum cholesterol levels will be assayed (references values <200 mg/dL).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

To diagnose NCWS the recently proposed criteria will be adopted. All the patients will meet the following criteria:

negative serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies;
absence of intestinal villous atrophy;
negative IgE-mediated immune-allergy tests to wheat (skin prick tests and/or serum specific IgE detection);
resolution of the IBS symptoms on standard elimination diet, excluding wheat, cow's milk, egg, tomato, chocolate, and other self-reported food(s) causing symptoms;
symptom reappearance on double-blind placebo-controlled (DBPC) wheat challenge. As the investigators previously described in other studies, DBPC cow's milk protein challenge and other "open" food challenges will be performed too.

Additional inclusion criteria will be:

age >18 years; follow-up duration longer than six months after the initial diagnosis;
at least two outpatient visits during the follow-up period.

Exclusion Criteria:

positive EmA in the culture medium of the duodenal biopsies, also in the case of normal villi/crypts ratio in the duodenal mucosa;
self-exclusion of wheat from the diet and refusal to reintroduce it, before entering the study;
other "organic" gastrointestinal disorders;
nervous system disease and/or major psychiatric disorder;
physical impairment limiting physical activity;
menopause;
steroid and sex steroid therapy, hormone replacement therapy or ovariectomy.