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Celiac Disease Diagnosis in Patients With Weakly Positive Serum Anti-Transglutaminase: Duodenal Anti-Endomysium Assay.

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ClinicalTrials.gov Identifier: NCT02242123
Recruitment Status : Recruiting
First Posted : September 16, 2014
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pasquale Mansueto, University of Palermo

Brief Summary:
Celiac disease (CD) is a chronic immune-mediated disorder that occurs in genetically predisposed populations. Patients affected by the disease may be asymptomatic or manifest classic malabsorption symptoms of diarrhea, steatorrhea, abdominal pain, and weight loss after gluten ingestion (and related derivatives found in other grains). Diagnosis and screening begin with the use of serologic tests, i.e. IgA anti-tissue transglutaminase (tTG) and IgA anti-endomysial antibodies (EmA). Duodenal biopsy, still considered by many as the criterion necessary for diagnosis, demonstrates the pathologic findings of small intestinal villous atrophy, crypt hyperplasia, and intraepithelial lymphocytosis that occur on exposure to dietary gluten. Genetic tests, revealing permissive haplotypes, may be helpful in identifying susceptible individuals. CD diagnosis is still anchored to the criteria established by the European Society of Pediatric Gastroenterology Hepatology and Nutrition in 1990. These require the mandatory presence of (a) villous atrophy with crypt hyperplasia and increased intraepithelial lymphocytes (IELs) count when the patient is eating gluten, and (b) a full clinical remission after elimination of gluten from the diet. As a consequence, patients with minimal or no intestinal histology lesions pose a considerable problem, as serum anti-tTG and EmA are known to be often negative, or weakly positive, in patients with CD with mild intestinal damage. The investigators, in 2002, measured anti-tTG antibody in the culture medium of intestinal biopsy specimens from patients with suspected CD and evaluated the relationship between antibody production and severity of intestinal mucosal damage, and demonstrated that anti-tTG assay of the culture medium of biopsy specimens can improve the accuracy of CD diagnosis in patients negative for serum antibodies. The same investigators, in 2011, evaluated the diagnostic accuracy of EmA assay in the culture medium of intestinal biopsies for CD diagnosis and demonstrated that EmA assay in the culture medium had a higher sensitivity and specificity than serum EmA and anti-tTG assay. The present study is performed to investigate the clinical usefulness of the in vitro production of EmA in CD diagnosis in a large number of consecutive adult patients with suspected CD and weakly positive [e.g. 2-3xN] serum anti-tTG.

Condition or disease
Celiac Disease

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Antiendomysium Antibodies Assay in the Culture Medium of Intestinal Mucosa: an Accurate Method for Celiac Disease Diagnosis in Patients With Weakly Positive Serum Anti-transglutaminase Antibodies.
Actual Study Start Date : January 2012
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Group/Cohort
Study group
Symptomatic patients, with weakly positive serum anti-tTG and evidence of mild intestinal histology damage (grade 1-2) at first evaluation.
Control group
Symptomatic patients, with weakly positive serum anti-tTG and evidence of intestinal villous atrophy (intestinal histology damage grade 3) at first evaluation.



Primary Outcome Measures :
  1. Changes in the intestinal histology of the patients with clinically suspected CD and weakly positive [e.g. 2-3xN] serum anti-tTG antibodies, at the time of the first evaluation. [ Time Frame: At baseline (first evaluation) and after at least one year since the first evaluation for suspected CD. ]
    Intestinal histology re-evaluation after at least one year after the first evaluation for suspected CD, without any dietary restriction. Marsh-Oberhuber's classification will be adopted: change from baseline (1st evaluation) to 2nd evaluation


Secondary Outcome Measures :
  1. Serum IgA anti-tTG antibodies evaluation. [ Time Frame: At baseline (first evaluation) and after at least one year since the first evaluation for suspected CD. ]
    Evaluation of changes in serum levels of IgA anti-tTG antibodies after at least one year since the first evaluation for suspected CD, without any dietary restriction.

  2. Symptoms/signs evaluation. [ Time Frame: At baseline (first evaluation) and after at least one year since the first evaluation for suspected CD. ]
    The evaluation of changes in symptoms/signs will be made according to the score calculated on the basis of the Visual Analogue Scale after at least one year since the first evaluation for suspected CD, without any dietary restriction.


Other Outcome Measures:
  1. EmA assay in duodenal biopsies evaluation. [ Time Frame: At the time of first duodenal histology evaluation. ]
    EmA assay in the culture medium of duodenal biopsies will be performed in all the patients, both Study and Control group, at the time of the first duodenal histology evaluation.

  2. Human leukocyte antigen (HLA) evaluation. [ Time Frame: At baseline (first visit). ]
    All the patients will undergo human leucocyte antigen (HLA) typing for DQ2 and DQ8 alleles determination.


Biospecimen Retention:   Samples Without DNA
Duodenal biopsy specimens


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will include consecutive patients, referred to two centers in Palermo and Sciacca, at the Internal Medicine Department of the University Hospital of Palermo, and at the Internal Medicine Department of the Hospital of Sciacca (Agrigento), between January 2014 and June 2016.
Criteria

Inclusion Criteria:

  1. adult patients, both genders, aged between 18-70 years;
  2. with suspected CD (i.e. affected with one or more of the following symptoms: chronic diarrhea or constipation, alternating bowel habits, abdominal pain, dyspepsia, recurrent aphthosis, dental enamel defects, thyroiditis, dermatitis, osteoporosis, joints pain, weight loss, anemia, cryptogenetic hypertransaminasemia);
  3. with weakly positive [e.g. 2-3xN] serum anti-tTG antibodies; and d) subjects with a family history of CD.

Exclusion Criteria:

- patients with IgA deficiency, type 1 diabetes, inflammatory bowel diseases (Crohn's disease or ulcerative colitis), Helicobacter pylori infection and other gastrointestinal infection, and 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): NCT02242123


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
Internal Medicine Department of the Hospital of Sciacca (Agrigento) Recruiting
Sciacca, Agrigento, Italy, 92019
Contact: Antonio Carroccio, MD, PhD    +39-091-6554347    acarroccio@hotmail.com   
Contact: Pasquale Mansueto, MD    +39-091-6554347    pasquale.mansueto@unipa.it   
Principal Investigator: Antonio Carroccio, MD, PhD         
Internal Medicine Department of the University Hospital of Palermo Recruiting
Palermo, Italy, 90127
Contact: Pasquale Mansueto, MD    +39-091-6554347    pasquale.mansueto@unipa.it   
Principal Investigator: Pasquale Mansueto, MD         
Sponsors and Collaborators
University of Palermo
Investigators
Principal Investigator: Antonio Carroccio, MD, PhD Internal Medicine Department of the Hospital of Sciacca (Agrigento)

Publications of Results:
Responsible Party: Pasquale Mansueto, Principal investigator, University of Palermo
ClinicalTrials.gov Identifier: NCT02242123     History of Changes
Other Study ID Numbers: ACPM05
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pasquale Mansueto, University of Palermo:
Celiac Disease
Gluten-free diet
EmA assay
Duodenal culture medium

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases