Schizophrenia
Conditions
Interventions
Consuming two sachets of probiotics per day for 4 weeks
Sponsors
Hokkaido University Hospital Department of Psychiatry and Neurology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are seen at regularly and irregularly scheduled consultation and not admitted to hospital more than 6 months after last discharge 2. Subjects who have anxiety and depressive symptoms that are rated 10 or more points on Brief Psychiatric Rating Scale anxiety and depressive items (1,2,5,9) 3. Subjects who provide written informed consent to participate in the study with sufficient understanding and of their own volition after receiving comprehensive explanation of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects who have uncontrolled diseases or untreatable malignant tumor. 2. Subjects who have cognitive impairment disorder or disturbance of consciousness 3. Subjects who have severe idea of suicide or symptoms that require to urgent treatment 4. Subjects who want to take medications for anxiety or depressive symptoms 5. Subjects who have taken antidepressants in the last month 6. Subjects whose daily intake of food or supplements includes Bifidobacterium 7. Subjects who daily consume a high amount of alcohol (more than 500 ml of beer per day) 8. Subjects who have mental disorders not including schizophrenia, mood disorder, or anxiety disorder 9. Subjects who are deemed to be inappropriate to participate in this study, by the physician in charge of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The correlation coefficient between increase in the Bifidobacterium occupancy rate and decrease in HADS score for 4 weeks in low Bifidobacterium group | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Completion rate for 4 weeks and its 95% confidence interval 2. Adverse effects: incidence rates of adverse events after 4 and 8 weeks and their 95% confidence intervals 3. The correlation coefficient among intestinal microbiota composition, Simpson's reciprocal index, which indicate the diversity of intestinal microbiota composition, Food Frequency Questionnaire(FFQ), Hospital Anxiety and Depression Scale(HADS), Positive and negative symptom scale(PANSS), Profile of Mood States(POMS), Schizophrenia Quality of Life Scale(JSQLS) at baseline 4. The correlation coefficient between increase in the Bifidobacterium occupancy rate and decrease in HADS, PANSS, POMS and JSQLS scores after 4 weeks in all subjects 5. The correlation coefficient between increase in intestinal microbiota composition and decrease in HADS, PANSS, POMS and JSQLS scores after 4 weeks in all subjects 6. Blood samples: the amount of change in metabolites such as nucleic acids, protein, glucose, organic acids and amino acids and multiple cytokines and chemokines after 4 and 8 weeks 7. Body weight and glycolipid metabolism: the changes in body weight, blood glucose level, HbA1c, GOT, GPT, LDH, gamma-GTP, CRP, Total Cholesterol, HDL Cholesterol, and Triglyceride after 4 and 8 weeks | — |
Countries
Japan
Contacts
Public ContactRyo Okubo
Hokkaido University Hospital Department of Psychiatry and Neurology
Outcome results
None listed