Abdominal Ultrasound Examination in Non-celiac Wheat Sensitivity

January 9, 2017 updated by: Pasquale Mansueto, University of Palermo

Abdominal Ultrasound Examination in Patients Affected With Non-celiac Wheat Sensitivity

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. The clinical picture of NCWS is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). Nowadays no data are available on the abdominal ultrasonographic features of NCWS patients. Therefore, the aim of the present study is to evaluate the abdominal ultrasonographic features of NCWS patients in comparison with patients affected with celiac disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. The clinical picture of NCWS is characterized by combined gastrointestinal (bloating, abdominal pain, diarrhea and/or constipation, nausea, epigastric pain, gastroesophageal reflux, aphthous stomatitis) and extra-intestinal and/or systemic manifestations (headache, depression, anxiety, 'foggy mind,' tiredness, dermatitis or skin rash, fibromyalgia-like joint/muscle pain, leg or arm numbness, and anemia). The researchers have just demonstrated in patients affected with seronegative celiac disease that the presence of dilated bowel loops and a thickened small bowel wall had a sensitivity of 83% and a negative predictive value of 95% in CD diagnosis. Considering the presence of one of these two signs, abdominal US sensitivity increased to 92% and negative predictive value to 98%. Nowadays no data are available on the abdominal ultrasonographic features of NCWS patients. Therefore, the aim of the present study is to evaluate the abdominal ultrasonographic features of NCWS patients in comparison with patients affected with celiac disease.

Study Type

Observational

Enrollment (Actual)

100

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

  • Italy
      • Palermo, Italy, 90129
        • Department of Internal Medicine, University Hospital of Palermo
    • Agrigento
      • Sciacca, Agrigento, Italy, 92019
        • Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca

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 included consecutive adult patients with IBS-like clinical presentation, according to Rome III criteria, and a definitive diagnosis of NCWS, referred at the Department of Internal Medicine at the University Hospital of Palermo, Italy, and at the Department of Internal Medicine of the Hospital of Sciacca, Agrigento, Italy, between January 2015 and November 2016, and sex- and age-matched subjects with CD, enrolled at the same centers, as controls patients. All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.

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.

To diagnose CD the standard criteria will be adopted. All the patients will meet the following criteria:

  • positive serum anti-transglutaminase (anti-tTG) and anti-endomysium (EmA) immunoglobulin (Ig)A and IgG antibodies
  • presence of intestinal villous atrophy.

Exclusion Criteria:

NCWS diagnosis excluded patients with:

  • 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 previously diagnosed gastrointestinal disorders
  • nervous system disease and/or major psychiatric disorder
  • physical impairment limiting physical activity.

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
Intervention / Treatment
NCWS patients
Fifty consecutive adult patients with an IBS-like clinical presentation, according to Rome III criteria, and a definitive diagnosis of NCWS. The patients was recruited between January 2015 and November 2016 at 2 centers: the Department of Internal Medicine at the University Hospital of Palermo, Italy, and the Department of Internal Medicine of the Hospital of Sciacca, Agrigento, Italy. All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.
Other: Abdominal ultrasound examination
All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.
CD control patients
To compare the abdominal ultrasonographic features of NCWS patients, a control group of CD patients was randomly chosen by a computer-generated method from subjects diagnosed during the same period and age- and sex-matched with the NCWS patients. All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.
Other: Abdominal ultrasound examination
All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal ultrasonographic features of NCWS and CD patients
Time Frame: from January 2015 to November 2016
Evaluation of abdominal ultrasonographic differences between NCWS and CD patients.
from January 2015 to November 2016

Collaborators and Investigators

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

Sponsor

University of Palermo

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

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 30, 2016

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimate)

January 11, 2017

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACPM20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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