Please select the eligibility criteria that correspond to the clinical trial below.
Title: Usefulness of Gluten-free Diet in Gluten-genetically Predisposed Subjects Positive to Intestinal-mucosa Anti-transglutaminase Antibodies
Brief Summary: Undetected or untreated CD may cause severe complications later in life, such as autoimmune disorders.

It is recommended for subjects with autoimmune diseases or at risk for CD to be screened for CD and to repeat serological screening about every three years to detect cases of clinically silent, late-onset CD.

Celiac disease (CD) auto-antibodies against tissue transglutaminase (anti-tTG) are produced in the intestinal mucosa even when not measurable in serum. By using the phage display libraries technique it is possible to investigate in vivo (intestinal biopsy) early antibody responses in autoimmune disease. In particularly, this technique demonstrated that the humoral response against tissue transglutaminase occurs at the intestinal mucosal level, and that the human VH5 gene is the commonly used variable region by the celiac patients to build the anti-tTG. The intestinal mucosa production of IgA anti-tTG could be important in the diagnostic work-up of early-stage CD, when mucosal histology is not yet diagnostic.

The investigators propose to 1) first degree relatives of CD patients, 2) subjects with autoimmune disease, 3) symptomatic subjects (genetically predisposed to gluten intolerance) tested negative for CD related autoantibodies and with apparently normal intestinal mucosa a prospective study to uncover early-stage of gluten intolerance by measuring the mucosal VH5 restricted gene family anti-tTG clones in two biopsies: before and after one year of gluten free-diet (GFD).

Aims of this clinical trial are:

1. to measure by means of phage display libraries the gluten dependent humoral immune response (anti-tTG) of the intestinal mucosa in subjects with high risk of untreated CD, without CD-related intestinal lesions.
2. to demonstrate the mucosal gluten-dependent immune response before and after 12 months of gluten-free diet
3. to demonstrate that dietary intervention might modify the clinical condition (e.g improvements of the gastrointestinal complaints or extra-gastrointestinal symptoms) of the enrolled patients and the improvement of the intestinal inflammation with the disappearance of the mucosal anti-tTG.
4. to evaluate the specificity of the double staining technique for detecting IgA antitransglutaminase mucosal deposit with the phage display antibodies assay


Options:
A: Inclusion Criteria:

* Positive endomysial antibodies
* Adults

Exclusion Criteria:

* Previous celiac disease diagnosis
* Significant clinical symptoms
* Suspicion of any serious celiac disease-associated complication
* Suspected or diagnosed severe illness other than celiac disease
* Consuming oral corticosteroids or immune suppressants
* Marked laboratory abnormalities
B: Inclusion Criteria:

* a gluten-containing diet for at least six months before enrollment
* anti-transglutaminase antibodies (IgA and IgG) absence
* normal serum IgA levels
* prick and specific IgE tests for wheat allergy negative

Exclusion Criteria:

* celiac disease
* wheat allergy
* chronic intestinal inflammatory diseases
* psychiatric disorders
* major abdominal surgery (in particular intestinal resections)
* diabetes mellitus
* previous anaphylactic episodes
* gluten-free diet in the previous six months
* pregnant or lactating women.
C: Inclusion Criteria:

* Children aged 3-5 and 11/12 years with a diagnosis of ASD
* GFD for at least 8 weeks prior to enrollment
* Minimal scores of 15 on SCQ
* Minimal scores 70 points on Leiter scale
* Consent of caregivers to participate in the study

Exclusion Criteria:

* Gluten-mediated disease (celiac disease, wheat allergy)
* Lack of motivation / opportunity to follow a diet
* Malnutrition (defined according World Health Organization - WHO standards as weight for height \<-2 SDS - Standard Deviation Scores)
D: Inclusion Criteria:

* first degree relatives of CD patients
* subjects with autoimmune disease tested negative for serum anti-tTG but positive for CD related HLA DQ2 or DQ8
* symptomatic subjects (genetically predisposed to gluten intolerance) tested negative for CD related autoantibodies and with apparently normal intestinal mucosa.

Exclusion criteria:

- None

Answer: D