Malnutrition In Non-Celiac Wheat Sensitivity Patients

Completed

• Conditions: Non-Celiac Wheat Sensitivity

• Registration Number: NCT02421796
• Lead Sponsor: University of Palermo

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.

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 Timeline

• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-21
• Study Start: 2015-05-01
• Primary Completion: 2016-10-01
• Study Completion: 2019-06-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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).

Trial Locations

Locations (2)

Antonio Carroccio; 🇮🇹 Sciacca, Agrigento, Italy

Pasquale Mansueto; 🇮🇹 Palermo, Italy