Please select the eligibility criteria that correspond to the clinical trial below.
Title: Gluten Dietary Intervention for Autistic Symptoms in Children With Autism Spectrum Disorders - Randomized Open Trial
Brief Summary: BACKGRUOUND: Autism spectrum disorder (ASD) is a common condition. The etiology of ASD remains unknown. Recent studies suggest a link between elimination diets and severity of autistic symptoms. The possible effects of a gluten-free diet (GFD) on symptoms remain unknown.

AIM: The aim of the study is to evaluate the impact of gluten challenge on the autistic symptoms in children with autism spectrum disorders (ASD) and on a gluten-free diet (GFD) in comparison to individuals continuing GFD.

METHODS: 70 children with ASD aged 3-5 and 11/12 remaining on GFD for at least 8 weeks will be randomly assigned to gluten-free and gluten-challenge diet.


Options:
A: 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)
B: 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
C: 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.
D: 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.

Answer: A