Schizophrenia
Conditions
Interventions
Clostridium butyricum M588 MIYA-BM Dosage:1g Method of administration:Every meal 3 times a day Administration period:4 weeks
Lactose Dosage:1g Method of administration:Every meal 3 times a day
Sponsors
Fujita Health University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.In participating in this research, after having received sufficient explanation, with sufficient understanding, the patient who got document consent by his / her own free will 2.Patients aged 20 years or older and under 75 years of age at consent acquisition, regardless of sex 3.Patients diagnosed with schizophrenia in Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV-TR 4.Patients diagnosed with functional constipation in ROME III 5.Fujita Health University Hospital Psychiatric department bedside hospitalized patients 6.Patients who are presenting constipation as side effects by using antipsychotics for the treatment of schizophrenia
Exclusion criteria
Exclusion criteria: 1.Comatose patient 2.Patients under the strong influence of central nervous system depressants such as barbiturates, anesthetics 3.Patients under the influence of epinephrine 4.Patients under the influence of neurostimulatory substances such as stimulants and alcohol 5.Patients with a history of hypersensitivity to the ingredients of this drug 6.Patients who may be pregnant and pregnant 7.Patients with mental retardation 8.Patients with dementia combined 9.Patients with personality disorder complications 10.Patients diagnosed with irritable bowel syndrome by ROME III 11.Patients complicated of digestive organ diseases other than constipation 12.Patients already using live bacteria such as lactic acid bacteria and butyric acid bacteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scoring the degree of improvement of constipation using Clinical Global Impression-Improvement (CGI-I) before and after administration of drug for 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight Vital sign(Body temperature,Blood pressure,Heart rate,Respiratory rate) Stool frequency Bristol stool form score Presence or absence of flatus Presence of remaining flight Number of times the laxative dose has been used Using Clinical Global Impression-Severity (CGI-S), evaluate mental symptoms before and after administration of the drug | — |
Countries
Japan
Contacts
Public ContactYuki Matsui
Fujita Health University School of Medicine Department of Psychiatry
Outcome results
None listed