The Influence of Probiotics on Body and Mind in Individuals With Psychiatric Disorders - a Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in fecal zonulin levels [ng/ml]
研究概览
简要总结
The aim of this study is to explore the effects of probiotics in individuals with a clinically relevant depression on psychiatric symptoms and cognition, inflammatory parameters, as well as gene-expression. The study is conducted as a placebo-controlled, randomized, double-blind, prospective, monocentric clinical study, with a two-arm parallel group design. Individuals in the intervention group receive the multispecies probiotics "Omnibiotics Stress Repair" in addition to vitamin B7, while individuals in the control group receive "Placebo" in addition to vitamin B7.
详细描述
The study takes places at the Medical University of Graz, Department of Psychiatry and Psychotherapeutic Medicine. Individuals that start inpatient treatment at the ward in the first floor of the Department because of a major depressive episode are eligible. After inclusion into the study, the participants are asked to fill in different self-rating questionnaires (Becks-Depression Inventory-II BDI-II, Symptom Checklist-90-Revised SCL-90-R, Manie-Selbstbeurteilungsskala german adaptation of Self-Report manic inventory (SRMI) - MSS, food frequency questionnaire). General data are explored routinely, as well as a diagnostic interview (MINI - mini international neuropsychiatric interview, German version 5.0) is performed during the stay at the hospital. Participants are asked to provide a stool probe as soon as possible.
At the day after admission, fasting blood is taken (100ml). Routine parameters are further analyzed at the local laboratory, while the rest is stored at -80 degree for later analyzes. Afterwards a cognitive test-battery is performed to measure verbal learning and memory, information processing speed, cognitive flexibility and working memory capacity.
After one week a further stool probe is taken, to measure possible changes in dietary habits due to the stay at the hospital. Antidepressive treatment at the hospital is continued as treatment as usual.
At the end participants go through a similar cognitive test battery as at the beginning and are asked to fill in the same self-rating questionnaires. If participants are discharged before day 28 they are given their own preparation and instructed to take it at home in the exact same manner. An outpatient appointment at the end of the preparation intake is arranged to collect the fasting blood and stool sample and to perform the cognitive assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of mood (affective) disorders (ICD 10 F3xx)
- •or neurotic, stress-related and somatoform disorders (ICD 10 F4xx),
- •inpatient treatment at the ward in the first floor of the Department of Psychiatry and Psychotherapeutic Medicine in Graz
- •written informed consent
排除标准
- •acute suicidality and potential dangers for themselves or other persons
- •intake of antibiotics during the last month
- •intake of food supplement with probiotic cultures or butyrate during the last year
- •persons who are incapable of giving consent
- •dementia (Mini Mental Status Examination ≤ 20)
- •mental retardation
- •misuse of laxatives and diuretics
- •acute or chronical gastrointestinal infection or diseases
- •pregnancy or breastfeeding period
- •acute tumor or autoimmune diseases
- •organic brain/mental disorders
- •active drug or alcohol abuse
研究组 & 干预措施
Intervention group
Probiotics and vitamin B7
干预措施: Probiotics and vitamin B7 (Dietary Supplement)
Control group
Placebo and vitamin B7
干预措施: Placebo and vitamin B7 (Dietary Supplement)
结局指标
主要结局
Changes in fecal zonulin levels [ng/ml]
时间窗: 28 (+/- 2) days
Stool diagnostics is performed by Biovis
Changes in fecal butyrate levels [μmol/g]
时间窗: 28 (+/- 2) days
Stool diagnostics is performed by Biovis
Changes in depressive symptoms [BDI-II - total score]
时间窗: 28 (+/- 2) days
Self-rating of depressive symptoms by the patient with Beck Depression Inventory-II (Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. Journal of Personality Assessment. 1996;67 (3): 588-97.)
Changes in overall psychological distress [SCL-90-R9 - GSI]
时间窗: 28 (+/- 2) days
GSI - global severity index of Symptom Checklist-90-Revised (Franke, GH. SCL-90-R. Die Symptom-Checkliste von Derogatis-Deutsche Version. Göttingen: Beltz, 1995.)
Changes in gastrointestinal quality of life [total score]
时间窗: 28 (+/- 2) days
Gastrointestinal quality of life index (Eypasch E, Wood-Dauphinée S, Williams JI, et al. The Gastrointestinal Quality of Life Index. A clinical index for measuring patient status in gastroenterologic surgery. Chirurg. 1993;64(4):264-274.)
Changes in depressive symptoms [HAM-D - total score]
时间窗: 28 (+/- 2) days
Clinical assessment of Hamilton Rating Scale for Depression (Hamilton, M. A rating scale for depression. Journal of Neurology, Neurosurgery and Psychiatry. 1960;23: 56-62)
次要结局
未报告次要终点