Please select the eligibility criteria that correspond to the clinical trial below.
Title: Double Blind Randomized Clinical Trial in Subjects With Irritable Bowel Syndrome for the Identification of Gluten Sensitivity
Brief Summary: The aim of our study will be to establish in how many subjects with gastrointestinal symptoms and previous diagnosis of irritable bowel syndrome (IBS), the clinical picture is attributable to non celiac gluten sensitivity (NCGS) or fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) intolerance. For this purpose, all subjects with IBS will take a low FODMAPs diet, which implies the absence of cereals and consequently of gluten, and those presenting symptom improvement during this dietary treatment, will be exposed to a double-blind gluten or placebo challenge, to make a diagnosis of NCGS.


Options:
A: Inclusion Criteria:

* Patients previously diagnosed with NCWS by DBPC challenge.

Exclusion Criteria:

* The 22 patients, included in the previous study, who tested positives for anti-endomysial antibodies (EmA) in the culture medium of the duodenal biopsies, even if the villi/crypts ratio in the duodenal mucosa was normal, were excluded from the present study.
B: 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
C: Inclusion Criteria:

1. Giving written informed consent
2. Patients with age ≥18 years
3. Histological diagnosis confirmed of lymphocytic enteritis (LE)
4. Celiac genetic study (HLA-DQ2 and /or HLA-DQ8 positive)
5. Negative serology of celiac disease
6. Previous complete clinical and histological response to gluten-free diet
7. Initial (at diagnosis) GI symptoms with or without extraintestinal manifestations.
8. No previous studies on both IEL cytometric pattern and anti-TG2 IgA subepithelial deposits.

Exclusion Criteria:

1. Patients who are unable to adhere to the study visit schedule and other protocol requirements according to the investigator.
2. Participation in a clinical trial in the last 30 days, simultaneous participation in a trial or prior participation in this study.
3. Previous diagnosis with gluten-sensitive enteropathy with villous atrophy and positive serology.
4. Patients with LE and initial response to gluten free diet but that at the time of inclusion are on a normal gluten-containing diet.
5. Severe co-morbidities.
6. Drug or alcohol abuse.
7. Pregnancy or breast-feeding.

At the initial diagnosis, other LE aetiologies, like non-steroidal anti-inflammatory drugs intake, parasitic infection, and Helicobacter pylori infection, were appropriately ruled out.
D: 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.

Answer: D