Probiotics Therapy: a New Approach to Therapy of Mood Disorders in Perimenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Dietary intervention
研究概览
简要总结
The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.
详细描述
The aim: The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.
The study hypothesis: By using periodic probiotics therapy it is possible to positively influence the mood of women with depressive syndromes. These efforts focus on the improvement of the functioning of the gut barrier and gut-brain axis. In practice, such activities should lead to the reduction in the dysfunction of the barrier, the reduction of endotoxemia and the concentration of neurotoxic metabolites of tryptophan (in blood) with the simultaneous increase in the content of butyric acid that has a neuroprotective effect.
The of the trial: intervention, cohort, randomized, double-blind, using placebo. A multi-strain probiotic will also be provided ( Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19 and Lactococcus lactis W58 or maize starch, maltodextrins and vegetable protein/placebo).
The applied method of study:
- a controlled dietary intervention that includes probiotics therapy; the verification of the past nutritional pattern (the Food Frequency Questionnaire); anthropometric measurements;
- psychiatric studies: the evaluation of sleep disorders (the Athens insomnia scale) and mood (the Beck scale), and the worsening of depression (the Hamilton scale);
- biochemical studies: the content of short chain fatty acids (in the stool);
- cytometric studies (B-type lymphocytes' panel, T-type lymphocytes' panel, regulatory T cells' panel);
- genetic (the microbiome of bacteria in the stool, pyrosequencing);
- chromatographic (the derivatives of tryptophan e.g., kynurenine, anthranilic acid, kynureic acid, 3-hydroxykynurenine, 5-hydroxytryptophan, serotonin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants and investigators enrolling participants could not foresee assignment because to conceal allocation equentially numbered probiotic containers of identical appearance was used
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •must presence of mood disorders confirmed by Beck scale (more than 10 points)
- •must be able to swallow tablets
排除标准
- •individuals that had prescribed antibiotics, proton pump inhibitors, or probiotics in the 6 months preceding the study (eg. inflammatory bowel syndrome)
- •circulatory disorders patients
- •diagnosed coagulopathies,
- •diagnosed respiratory disease
- •inflammatory bowel disease patients
- •addicted to alcohol
- •addicted to psychoactive substances,
结局指标
主要结局
Dietary intervention
时间窗: 5 weeks
The verification of the past nutritional pattern (will be asses by Food Freguency Questionnarie). The indicate frequency of food consumption, respondents could choose one of six categories (next converted by researcher into daily frequency): never or very rarely (0 times/day), once a month or less (0.025 times/day), several times a month (0.1 times/day), several times a week (0.571 times/day), daily (1 time/day), or a few times a day (2 times/day)
Anthropometric measurements
时间窗: 5 weeks
The verification of body mass during the study will be asses by body mass index (BMI). In order of this, we will measure the height (outcome in cm). BMI will be calculated by dividing body weight (in kilograms) by height squared (in meters).i Finally BMI will be presented in kg/m2.
Depression intensity mesurements
时间窗: 5 weeks
Depression intensity will be asses by the Hamilton Rating Scale for Depression (HRSD).Unit HRSD ( 0-7 not depressed, 8-13 mild depression; 14-18 moderate depression (mild); 19-22 moderate depression; \> 23 severe depression)
The biochemical changes in stool
时间窗: 5 weeks
Observation of biochemical changes short fatty acids (SCFAs) concentration before and after the intervention (SCFA in ng/ml)
The cytometric studies
时间窗: 5 weeks
Observation of a change in Mean Fluorescence Intensity (FSC) of lymphocytes B and regulatory T cells before and after intervention in flow cytometry. Assessments by median: midpoint of the population (middle channel)).
The stool microbiota changes
时间窗: 5 weeks
Changes in gut microbiota composition and metabolism (16 SrRNA bacterial genomic, bacterial metabolites) at enrollment and at the end-point ( gut microbiota will be asses in Operational taxonomic units (OTUs))
Insomnia studies
时间窗: 3 months
Assessments using unique measurements Athens insomnia scale ( 0 to \< 6 means no insomnia; more than 6 points indicated diagnosis of insomnia)
The Kynureine Pathway
时间窗: 3 months
The changes in the tryptophan pathway derivatives before and after intervention will be measured. ( we assess metabolites of kynurenine pathway e.g. 5 HT, HIAA, KYN will be asses by HPLC (in ng/ml)
次要结局
未报告次要终点
研究者
Ewa Stachowska
Professor, head of Department of Human Nutrition and Metabolimics. PhD
Pomeranian Medical University Szczecin