Malnutrition In Non-Celiac Wheat Sensitivity Patients

August 30, 2019 updated by: Pasquale Mansueto, University of Palermo
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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Palermo, Italy, 90127
        • Pasquale Mansueto
    • Agrigento
      • Sciacca, Agrigento, Italy
        • Antonio Carroccio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will include consecutive adult patients with irritable bowel syndrome (IBS)-like clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS, referred at the Internal Medicine and at the Gastroenterology Units of the University Hospital of Palermo, between may 2015 and may 2017.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in body mass index (BMI)
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.
At baseline and at 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Antonio Carroccio, PhD, Department of Internal Medicine, Giovanni Paolo II Hospital, Via Pompei, Sciacca, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Actual)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 30, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Celiac Wheat Sensitivity

3
Subscribe