The Influence of Probiotic Supplementation on the Severity of Anxiety and Depressive Symptoms, as Well as the Function and Composition of Gut Microbiota, Metabolic, Inflammation, and Oxidative Stress Markers in Patients With Depression
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The World Health Organization quality of life-BREF questionnaire (WHOQOL-BREF)
研究概览
简要总结
The aim of this study is to gather empirical evidence which will enable to evaluate the impact of probiotic supplementation on the severity of anxiety and depressive symptoms, function, and composition of gut microbiota, metabolic parameters, inflammation, and oxidative stress markers in patients with diagnosed depressive disorders.
The designed study will be prospective, randomized, placebo-controlled, and double-blind. The intervention period will last 8 weeks for each patient. The study will be conducted on 100 patients in total, who will be randomly divided into two groups, consisting of 50 patients each.
Patients included in Group I (PRO-D) will receive one capsule daily containing a probiotic mixture at a daily dose of 3×109 colony-forming units (CFU). The probiotic will be composed of two bacteria strains: Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175, and excipients: potato starch, magnesium stearate, and the capsule shell, made of hydroxypropylmethylcellulose.
Patients included in Group II (PLC-D) will receive daily the same capsule, containing only excipients: potato starch, maltodextrin, and the capsule shell. The color, smell, and taste of the placebo will not be different from those included in the probiotic capsule.
Patients will be considered compliant if they consume >= 80% of the supplements.
The primary outcome measures will be the severity of depressive anxiety and stress symptoms assessed with Montgomery-Åsberg Depression Rating Scale (MADRS) and the Depression, Anxiety, Stress Scale (DASS) with subscales scores, the quality of life level assessed with the WHOQOL-BREF instrument. The secondary outcomes measures will include: blood pressure (BP), body mass index (BMI) and waist circumference (WC) measures, fasting glucose (fGlc), HDL cholesterol (HDL-C), triglycerides (TG), white blood cells count (WBC), neutrofiles, serum levels of C-reactive protein (CRP), the level of faecal SCFAs, faecal microbiota α-diversity and the level of oxidative stress parameters (total antioxidant capacity (TAC) and malondialdehyde (MDA)) in the blood serum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind trial, independent researcher is responsible for randomization and blinding.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Depressive disorders diagnosed according to ICD-11,
- •Age between 18 - 70 years,
- •MADRS score >=13,
- •Antidepressant and antianxiety medications not changed 3 weeks prior to the recruitment visit.
排除标准
- •An infection/vaccination and/or treatment with antibiotics in the previous 4 weeks,
- •Supplementation with pro- or prebiotics in the previous 4 weeks,
- •Having a diagnosis of autoimmune, serious immunocompromised, inflammatory bowel diseases, cancer, IgE-dependent allergy, or severe kidney failure in the previous 4 weeks,
- •body mass index (BMI)> 35,
- •glomerular filtration rate (GFR)< 30 ml/min/1,72 m2,
- •unstable thyroid dysfunction (TSH < 0,27 or > 4,2 μIU/ml) in the previous 4 weeks,
- •Psychiatric comorbidities (except specific personality disorder, additional specific anxiety disorder, and caffeine, and nicotine addiction),
- •Regular treatment (more than 3 days a week) with PPIs, metformin, laxatives, systemic steroids, or NSAIDs in the previous 4 weeks,
- •Significant change in dietary pattern in the previous 4 weeks,
- •Significant change in daily physical activity or extreme sports activity in the previous 4 weeks,
- •Significant change in dietary supplementation in the previous 4 weeks,
- •Significant change in smoking pattern in the previous 4 weeks,
- •High risk of suicide,
- •Is participating in, or has recently participated in, another research study involving an intervention that may alter outcomes of interest to this study,
- •Any other condition or situation which, in the view of investigators, would affect the compliance or safety of the individual taking part.
- •Reasons for the participant to be discontinued from the study:
- •Withdrawal of informed consent,
- •An infection/vaccination and/or treatment with antibiotics during the trial,
- •Consuming any other than studied probiotics during the trial,
- •Lack of compliance with the probiotic supplementation,
- •Any change in the drug regimen during the study,
- •Exclusion criteria found after enrolment,
- •Any serious adverse event during the trial.
研究组 & 干预措施
Group I "PRO-D"
50 patients with diagnosed depressive disorders, meeting the criteria of International Classification of Diseases (ICD-11) for 6A70-73, 6A7Y, 6A7Z, taking a probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell.
干预措施: Probiotic composed of two bacteria strains: Lactobacillus helveticus Rosell and Bifidobacterium longum Rosell. (Dietary Supplement)
Group II "PLC-D"
50 patients with diagnosed depressive disorders, meeting the criteria of International Classification of Diseases (ICD-11) for 6A70-73, 6A7Y, 6A7Z, taking a placebo.
干预措施: control group (Other)
结局指标
主要结局
The World Health Organization quality of life-BREF questionnaire (WHOQOL-BREF)
时间窗: 8 weeks
6-item questionnaire evaluating four domains: physical health, psychological health, social relationships, and environment validated for several countries.
Depression, Anxiety, Stress Scale (DASS21)
时间窗: 8 weeks
21-item self-administered questionnaire, designed to measure the magnitude of three negative emotional states: depression, anxiety, and stress. These scores ranged from 0 ("did not apply to me at all") to 3 ("apply to me very much or most of the time").
Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: 8 weeks
10-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disturbances. The overall score ranges from 0 to 60 (most severe depression).
次要结局
- Neutrofiles count(8 weeks)
- Serum levels of C-reactive protein (CRP)(8 weeks)
- Waist circumference (WC)(8 weeks)
- White blood cells count (WBC)(8 weeks)
- Fasting glucose (fGlc)(8 weeks)
- Blood pressure (BP)(8 weeks)
- Body mass index (BMI)(8 weeks)
- The level of faecal short-chain fatty acids (SCFAs)(8 weeks)
- Faecal microbiota α-diversity(8 weeks)
- Total antioxidant capacity (TAC) in the blood serum(8 weeks)
- HDL cholesterol (HDL-C)(8 weeks)
- Triglycerides (TG)(8 weeks)
- Malondialdehyde (MDA) level in the blood serum(8 weeks)
研究者
Dominik Strzelecki
Professor, MD, PhD
Medical University of Lodz