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Diagnostic Significance of Positive EmA Antibodies in the Duodenal Culture Medium of Not-Celiac Wheat Sensitivity (NCWS) (NCWS)

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ClinicalTrials.gov Identifier: NCT02203201
Recruitment Status : Recruiting
First Posted : July 29, 2014
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Pasquale Mansueto, University of Palermo

Brief Summary:
The most frequent diseases caused by wheat ingestion are T cell-mediated disorders, i.e. celiac disease and immunoglobulin E (IgE)-mediated allergic reactions. However, besides celiac disease and wheat allergy, there are cases of gluten reactions in which neither autoimmune nor IgE-mediated allergic mechanisms are involved. These are generally defined as GS or Not-celiac wheat sensitivity (NCWS). Typically, NCWS diagnosis is made by exclusion, and an elimination diet and an "open challenge" (i.e., the monitored reintroduction of gluten-containing foods) are most often used to evaluate whether health improves or worsen with the elimination or reintroduction of gluten in the diet, respectively. In some circumstances, it is very difficult to distinguish between NCWS and celiac disease. The presence of positive celiac disease specific serum antibodies (anti-tissue transglutaminase (anti-tTG), and anti-endomysium (EmAs) antibodies) is of paramount importance to pose the diagnosis. However, it is well known that the frequency of a positive serology is dependent by the severity of the intestinal damage. Consequently, patients with less severe histology damage (Marsh 1) can have negative serum antibodies. Previous studies had demonstrated that EmAs are produced by the intestinal lymphocytes and previous data from our group showed that EmAs assay in the culture medium of the intestinal biopsies has higher diagnostic accuracy than serum EmAs in diagnosis. Therefore, the aims of our study are to evaluate the clinical-serologic-histology course of NCWS patients, showing positive EmAs assay in the culture medium of the duodenal biopsies at the time of the first evaluation, and the adherence to a gluten-free diet in NCWS patients after a previous full evaluation and a NCWS diagnosis based on double-blinded placebo-controlled (DBPC) challenge.

Condition or disease
Not-celiac Gluten Sensitivity

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Diagnostic Significance of Positive Anti-endomysium Antibodies in the Culture Medium of the Intestinal Biopsies in Not-Celiac Wheat Sensitivity (NCWS)
Actual Study Start Date : January 2014
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Study group
NCWS patients who had showed a negative celiac disease serology and a Marsh 0-1 duodenal histology, but who had displayed a positive EmA assay in the culture medium of the duodenal biopsies (EmA-biopsy).
Control group
NCWS patients with negative EmA-biopsy.



Primary Outcome Measures :
  1. Changes in the intestinal histology of NCWS patients who tested positives for EmAs in the culture medium of the intestinal biopsies, at the time of the first evaluation. [ Time Frame: At baseline and after at least one year since the initial NCWS diagnosis was posed. ]

    Intestinal histology re-evaluation after at least one year since the initial NCWS diagnosis was posed. Marsh classification will be adopted: change from baseline (1st evaluation) to 2nd evaluation.

    The above parameter will be evaluated taking into account whether the patients adhered or not to a wheat-free diet.



Secondary Outcome Measures :
  1. Serum anti-tTG antibodies evaluation. [ Time Frame: At baseline and after at least one year since the initial NCWS diagnosis was posed. ]
    Evaluation of changes in serum levels of anti-tTG antibodies after at least one year since the initial NCWS diagnosis was posed.

  2. Serum DPG antibodies evaluation. [ Time Frame: At baseline and after at least one year since the initial NCWS diagnosis was posed. ]
    Evaluation of changes in serum levels of DPG antibodies after at least one year since the initial NCWS diagnosis was posed.

  3. Serum AGA evaluation. [ Time Frame: At baseline and after at least one year since the initial NCWS diagnosis was posed. ]
    Evaluation of changes in serum levels of AGA after at least one year since the initial NCWS diagnosis was posed.

  4. Adherence to a wheat-free diet [ Time Frame: At baseline and after at least one year since the initial NCWS diagnosis was posed. ]
    Degree of adherence to a wheat-free diet since the initial diagnosis of NCWS was posed.

  5. Symptoms/signs evaluation. [ Time Frame: At baseline and after at least one year since the initial NCWS diagnosis was posed. ]
    The evaluation of changes in symptoms/signs will be made according to the score calculated on the basis of the Visual Analogue Scale since the initial diagnosis of NCWS was posed.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The investigators will include exclusively patients who had been previously fully evaluated for suspected celiac disease in our Hospitals (Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca, Agrigento, and of Internal Medicine of the University of Palermo) from January 2002 to December 2012. In all patients NCWS diagnosis had been posed by means of a double-blind placebo-controlled (DBPC) challenge with wheat flour.
Criteria

Inclusion Criteria:

  • Adult patients, both genders, with age between 18-65 years, that has been previously diagnosed as NCWS, according to a DBPC method
  • Patients testing negative for celiac disease ( anti-tTG and EMA negative, and with biopsy Marsh 0-1) and wheat allergy (serum specific igE for wheat negative)
  • Patients showed positive EmAs in the culture medium of the duodenal biopsies

Exclusion Criteria:

  • Subjects diagnosed with celiac disease (positive anti-tTG and/or EMA, and positive histology, with Marsh 2 or above)
  • Subjects diagnosed with wheat allergy (positive serum specific IgE for wheat)
  • Subjects with Type 1 Diabetes
  • Subjects with Inflammatory Bowel Diseases (Crohn's disease or ulcerative colitis)
  • Subjects with Helicobacter pylori infection and other gastrointestinal infection
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203201


Contacts
Contact: Antonio Carroccio, MD, PhD +39-091-6554347 acarroccio@hotmail.com
Contact: Pasquale Mansueto, MD +39-091-6554347 pasquale.mansueto@unipa.it

Locations
Italy
Department of Internal Medicine, Giovanni Paolo II Hospital of Sciacca Recruiting
Sciacca, Agrigento, Italy, 92019
Contact: Antonio Carroccio, MD, PhD    +390916554347    acarroccio@hotmail.com   
Department of Internal Medicine, University Hospital of Palermo Recruiting
Palermo, Italy, 90129
Contact: Pasquale Mansueto, MD    +390916554347    pasquale.mansueto@unipa.it   
Sponsors and Collaborators
University of Palermo
Investigators
Study Director: Antonio Carroccio, MD, PhD University of Palermo
Principal Investigator: Pasquale Mansueto, MD University of Palermo

Publications:
Responsible Party: Pasquale Mansueto, Researcher, University of Palermo
ClinicalTrials.gov Identifier: NCT02203201     History of Changes
Other Study ID Numbers: ACPM04
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017

Keywords provided by Pasquale Mansueto, University of Palermo:
Not-celiac gluten sensitivity
Celiac Disease
Gluten-free diet
EMA assay
Duodenal culture medium

Additional relevant MeSH terms:
Malabsorption Syndromes
Hypersensitivity
Celiac Disease
Immune System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs