Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 12-week, Randomized, Double-blind, and Placebo-controlled Study Evaluating the Effect of Probiotic Supplementation on the Mental Status, Inflammation, And Intestinal Barrier in Major Depressive Disorder Patients Using Gluten-free or Gluten-containing Diet
Brief Summary: More and more evidence confirms the relationship between the gut-brain-microbiota axis and the symptoms of mood disorders. A potential pathway connecting the intestines and the brain in depression is inflammation. Interventions for reducing inflammation and restoring the integrity of the intestinal mucosa are promising approaches in patients with major depressive disorder (MDD). Gut dysbiosis and the diet containing gluten are potential factors may be factors that negatively affect the communication between intestinal and brain. Gluten has a high immunogenic potential and affinity for the intestinal mucosa layer. In patients with an abnormal reaction to gluten, the elimination diet led to improved mood symptoms. However, the relationship between gluten and depression is still poorly understood. Intestinal microbiota can affect the digestion of gluten and reduce its immunogenic potential. Studies have shown that probiotic supplementation has an anti-inflammatory effect, can lead to changes in intestinal permeability and alleviate the symptoms of depression. This evidence supports the need for co-therapy, including the elimination of gluten and the restoration of intestinal eubiosis to reduce inflammation and modulate the gut-brain-microbiota axis. The objective of the SANGUT study is to determine the impact of interventions concerning the gut-brain-microbiota axis (probiotic supplementation, gluten-free diet and their combination) on the mental state, markers of inflammation and markers of intestinal permeability in adult patients with MDD. The study will last 12 weeks and consist of four visits (V): V0 - Screening (Day 0), V1 - Baseline (up to 1 week after Screening), V2 (six weeks after Baseline), V3 - End of the study (12 weeks after Baseline). The main hypothesis is that probiotic supplementation and/or a gluten-free diet will reduce the symptoms of depression, lower the level of inflammatory markers and favourably affect the integrity of the intestinal mucosal barrier.


Options:
A: Arm Label: Gluten-free diet; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Gluten-free diet | Intervention Type: DIETARY_SUPPLEMENT; Name: Gluten-free diet; Assigned to Arm(s): Gluten-free diet
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: 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
D: Arm Label: gluten-containing diet; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Active comparator, gluten-free diet; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Gluten-free diet | Intervention Type: DIETARY_SUPPLEMENT; Name: Gluten-free diet; Assigned to Arm(s): Active comparator, gluten-free diet

Answer: C