Please select the arm or intervention descriptions that belong 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: Arm Label: A - gluten challenge group; Type: EXPERIMENTAL; Interventions: Other: Gluten challenge | Arm Label: B - gluten-free diet; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Gluten challenge; Assigned to Arm(s): A - gluten challenge group
B: Arm Label: Group 1; Type: EXPERIMENTAL; Interventions: Other: Normal gluten containing bread | Arm Label: Group 2; Type: EXPERIMENTAL; Interventions: Other: Bread with reduced gliadins content | Arm Label: Group 3; Type: EXPERIMENTAL; Interventions: Other: Bread with reduced ATIs content | Arm Label: Group 4; Type: EXPERIMENTAL; Interventions: Other: Bread with reduced overall protein content | Intervention Type: OTHER; Name: Normal gluten containing bread; Assigned to Arm(s): Group 1 | Intervention Type: OTHER; Name: Bread with reduced gliadins content; Assigned to Arm(s): Group 2 | Intervention Type: OTHER; Name: Bread with reduced ATIs content; Assigned to Arm(s): Group 3 | Intervention Type: OTHER; Name: Bread with reduced overall protein content; Assigned to Arm(s): Group 4
C: Arm Label: patients with IBS treated with gluten; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: diet containing gluten | Arm Label: patients with IBS treated with placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Diet containing placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: diet containing gluten; Assigned to Arm(s): patients with IBS treated with gluten | Intervention Type: DIETARY_SUPPLEMENT; Name: Diet containing placebo; Assigned to Arm(s): patients with IBS treated with placebo
D: Arm Label: PRO-GFD; Type: EXPERIMENTAL; Interventions: Combination Product: Probiotic supplementation + gluten-free diet | Arm Label: PLA-GFD; Type: PLACEBO_COMPARATOR; Interventions: Combination Product: Placebo supplementation + gluten-free diet | Arm Label: PRO-GD; Type: EXPERIMENTAL; Interventions: Combination Product: Probiotic supplementation + gluten-containing diet | Arm Label: PLA-GD; Type: PLACEBO_COMPARATOR; Interventions: Combination Product: Placebo supplementation + gluten-containing diet | Intervention Type: COMBINATION_PRODUCT; Name: Probiotic supplementation + gluten-free diet; Assigned to Arm(s): PRO-GFD | Intervention Type: COMBINATION_PRODUCT; Name: Placebo supplementation + gluten-free diet; Assigned to Arm(s): PLA-GFD | Intervention Type: COMBINATION_PRODUCT; Name: Probiotic supplementation + gluten-containing diet; Assigned to Arm(s): PRO-GD | Intervention Type: COMBINATION_PRODUCT; Name: Placebo supplementation + gluten-containing diet; Assigned to Arm(s): PLA-GD

Answer: A