An interventional study of Probiotic supplementation + gluten-free diet and Placebo supplementation + gluten-free diet in Depressive Disorder, Major and Depression, sponsored by Medical University of Lublin. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-03-15.
Sponsored by Medical University of Lublin · Not applicable, Interventional, and Treatment
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.
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This study's planned enrollment of 120 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.
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Exclusion Criteria:
Probiotic supplementation + gluten-free diet
Combination Product: Probiotic supplementation + gluten-free diet
Placebo supplementation + gluten-free diet
Combination Product: Placebo supplementation + gluten-free diet
Probiotic supplementation + gluten-containing diet
Combination Product: Probiotic supplementation + gluten-containing diet
Placebo supplementation + gluten-containing diet
Combination Product: Placebo supplementation + gluten-containing diet
The probiotic and gluten-free diet group (PRO-GFD) will receive one capsule containing the probiotic mixture powder (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) in the amount of 3 × 10\^9 colony forming units (CFU) per day divided in two equal doses, comprising two bacteria strains: Lactobacillus helveticusRosell®-52, Bifidobacterium longumRosell®-175, and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. The participants will be asked to consume supplements before breakfast. The group will follow the elimination diet containing no gluten.
The placebo and gluten-free diet group (PLA-GFD) will receive one capsule containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell. The participants will be asked to consume supplements before breakfast. The group will follow the elimination diet containing no gluten.
The probiotic and gluten-containing diet group (PRO-GD) will receive one capsule containing the probiotic mixture powder (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) in the amount of 3 × 10\^9 colony forming units (CFU) per day divided in two equal doses comprising two bacteria strains: Lactobacillus helveticusRosell®-52, Bifidobacterium longumRosell®-175 and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. The participants will be asked to consume supplements before breakfast. The group will stay with their current diet.
The placebo and gluten-containing diet group (PLA-GD) will receive one capsule containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell. The participants will be asked to consume supplements before breakfast. The group will stay with their current diet.
The changes in Montgomery-Åsberg Depression Rating Scale(MADRS) total score to measure the severity of depression symptoms
A 10-item questionnaire to measure the severity of depressive symptoms in individuals with mood disorders. The assessment is performed by an experienced clinical psychiatrist. Each item yields a score of 0 to 6 (overall score ranges from 0 to 60). The higher score indicates a higher severity of the depressive episode. MADRS cut-off points include: * 0 to 6: symptom absent * 7 to 19: mild depression * 20 to 34: moderate depression * more than 34: severe depression
Time frame: from the date of randomization until the end of the study up to 12 weeks
The changes in Beck Depression Inventory (BDI) total score to measure the severity of depression symptoms
A 21-item multiple-choice self-report inventory to measure the severity of depression. Each item yields a score of 0 to 3 (overall score ranges from 0 to 63). The higher score indicates more severe depression symptoms. BDI cut-off points include: * 0 to 9: no/minimal depression * 10 to 18: mild depression * 19 to 29: moderate depression * 30 to 63: severe depression
Time frame: from the date of randomization until the end of the study up to 12 weeks
The changes in Symptom Checklist-90 (SCL-90) total score to measure the severity of psychopathological impairment
A 90-item self-reported inventory to evaluate a broad range of psychological problems and symptoms of psychopathology. The SCL-90 measure symptom intensity on nine different subscales: somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism. Each item yields a score of 0 to 4 (overall score ranges from 0 to 364). The higher score indicates more severity of symptoms.
Time frame: from the date of randomization until the end of the study up to 12 weeks
The changes in the 36-Item Short Form Survey (SF-36) total score to measure the quality of life
A 36-item self-reported survey to evaluate a health status including vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Raw scores are transforming to 0-100 scale. The higher score indicates a better health state.
Time frame: from the date of randomization until the end of the study up to 12 weeks
The changes in the Perceived Stress Scale (PSS-10) total score to measure the stress levels
A 10-item self-reported questionnaire to measure the perception of stress. Each item yields a score of 0 to 4 (overall score ranges from 0 to 40). The higher score indicates higher perceived stress.
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of high-specific C-reactive protein (hs-CRP)
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of interleukin 6 (Il-6)
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of interleukin 1beta (Il-1beta)
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of tumor necrosis factor alpha (TNF-alpha)
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of anti-tissue transglutaminase (anti-TG2) IgG antibodies
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of anti-gliadin (anti-AGA) IgG antibodies
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of anti-gliadin (anti-AGA) IgA antibodies
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of intestinal fatty acid-binding protein (I-FABP/FABP-2)
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of lipopolysaccharide biding protein (LBP)
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of total cholesterol
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of low-density lipoprotein (LDL) cholesterol
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of high-density lipoprotein (HDL) cholesterol
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of triglycerides (TG)
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of glucose
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of insulin
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of cortisol
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of alanine aminotransferase (ALT)
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in serum levels of aspartate aminotransferase (AST)
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in diversity in microbial community in a single sample (alpha-diversity)
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in diversity in microbial community between samples (beta-diversity)
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in stool short-chain fatty acids (SCFAs) levels
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in electroencephalography (EEG) analysis to assess the functional connectivity (FC)
FC will be assessed, based on resting-state EEG-recordings, with the application of a Phase Lag Index (PLI), measuring connectivity strength between a given pair of cortical areas. The global neural network organization will be analyzed with Minimum Spanning Tree algorithm.
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in Gastrointestinal Symptom Rating Scale (GSRS) total score to measure intensity of experienced gastrointestinal symptoms
A 15-item self-reported questionnaire to measure gastrointestinal symptoms in five clusters: reflux, abdominal pain, indigestion, diarrhoea and constipation. Each item yields a score of 0 to 3 (overall score ranges from 0 to 45). The higher score indicates a higher intensity of experienced symptoms.
Time frame: from the date of randomization until the end of the study up to 12 weeks
Changes in Trail Making Test (TMT) to measure the cognitive abilities
Time frame: from the date of randomization until the end of the study up to 12 weeks
Plan to share: No
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Medical University of Lublin