Please select the eligibility criteria that correspond to the clinical trial below.
Title: Non-Celiac Wheat Sensitivity: Permanent or Transient Condition? A Follow-up Study
Brief Summary: Non-Celiac Gluten Sensitivity (NCGS) has been recently included among the gluten-related diseases. Patients suffering from NCGS are diagnosed after carefully excluding celiac disease (CD), and immunoglobulin E (IgE)-mediated wheat allergy. Then, in the absence of sensitive and specific diagnostic biomarkers for NCGS, a monitoring of the patient during elimination and re-introduction of wheat by a double-blind placebo controlled (DBPC) challenge method has been suggested as diagnostic hallmark. Some studies seem to suggest that wheat components other than gluten can cause the symptoms, and therefore the term "non-celiac wheat sensitivity" (NCWS) has been proposed instead of NCGS. While it is well known that CD is a long-life condition and a strict adherence to the gluten-free diet must be maintained, it is unknown whether this is valid for NCWS. On the year 2012, the researchers published a retrospective study, including 276 patients with irritable bowel syndrome (IBS)-like symptoms who had been diagnosed with NCWS using a DBPC challenge during a ten-years period (2001-2011). The present prospective study aimed to evaluate: A) how many of these patients are still following a wheat-free diet, and B) which percentage was still suffering from NCWS, diagnosed by DBPC wheat challenge, in a subgroup of that cohort.


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:

1. Outpatients aged 18-60 years old;
2. Signed written Informed Consent Form;
3. Meet the DSM-5 criteria for MDD;
4. Body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2;
5. MADRS (Montgomery-Asberg Depression Scale) total score at screening (V0) and at baseline (V1) of 20 points or more (moderate or severe depression);
6. A willingness and motivation to follow the study protocol.

Exclusion Criteria:

1. Diagnosis of autoimmune, neurological, immunocompromised, thyroid, inflammatory bowel diseases, diabetes, cancers, and/or IgE-dependent allergy;
2. Psychiatric comorbidities (except specific personality disorder) including mental retardation, organic brain dysfunction, or addiction (except nicotine and caffeine);
3. High risk of suicide in the investigator's opinion;
4. An infection one month before the study baseline visit (V1);
5. The use of antibiotics and/or probiotics three months prior to the study;
6. Glucocorticosteroids and/or metformin treatment;
7. Intake of any other drugs which in the investigator' opinion may affect the results of study;
8. Intake of any dietary supplementation (except for vitamin D according to the "Vitamin D supplementation guidelines, 2018") which in the investigator' opinion may affect the results of the study;
9. Changes in a pharmacotherapy and/or psychotherapy of MDD 2 weeks before the trial entry;
10. Electroconvulsive therapy (ECT) 12 months before the trial entry;
11. No specific diet (e.g., elimination, vegan, reduction) and changes in physical activity 4 weeks before the trial entry;
12. Pregnancy or lactation.
C: Inclusion Criteria:

* male or female, aged 18-70, who believe they experience non-coeliac gluten sensitivity

Exclusion Criteria:

* Medical exclusion criteria

  * Coeliac Disease
  * Wheat allergy
  * Dermatitis Herpetiformis
  * Gastrointestinal disorders: Small Intestinal Bowel Overgrowth (SIBO), Crohn's disease , Ulcerative Colitis, Inflammatory Bowel Disease (IBD)
  * History of gastrointestinal surgery/procedure over the last 3 years
  * Kidney disease
  * Hepatic disease
  * Active cancer
  * Severe cardiovascular disease
  * Addiction to any substances
  * Breastfeeding/ Pregnancy

Volunteers with poorly controlled psychiatric disease or those unable to give written informed consent will also be excluded.

Medication exclusion criteria

* Medications for treatment of heartburn, dyspepsia, indigestion, bloating etc. e.g. gastrokinetics or prokinetics, antacids, laxatives
* Digestive enzymes
D: 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)

Answer: A