UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Clostridium butyricum M588 probiotics for the patients of constipation in schizophrenia: 4 weeks, a randomized, double blinded trial
Title of the study (Brief title)	A randomaized trial of Clostridium butyricum M588 probiotics for the patients of constipation in schizophrenia
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of Clostridium Butyricum M588 on constipation as side effect of antipsychotics with schizophrenia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Scoring the degree of improvement of constipation using Clinical Global Impression-Improvement (CGI-I) before and after administration of drug for 4 weeks
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Clostridium butyricum M588 MIYA-BM Dosage:1g Method of administration:Every meal 3 times a day Administration period:4 weeks
Interventions/Control_2	Lactose Dosage:1g Method of administration:Every meal 3 times a day Administration period:4 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key 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
Key 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
Target sample size	40

Research contact person
Name of lead principal investigator	Nakao Iwata
Organization	Fujita Health University
Division name	School of Medicine Department of Psychiatry
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake city Aichi prefecture, Japan
TEL	0562-93-9250
Email	nakao@fujita-hu.ac.jp

Public contact
Name of contact person	Yuki Matsui
Organization	Fujita Health University
Division name	School of Medicine Department of Psychiatry
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake city Aichi prefecture, Japan
TEL	0562-93-9250
Homepage URL
Email	yuki2250@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	Fujita Health University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 19 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 08 Month 10 Day
Anticipated trial start date	2016 Year 12 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 26 Day
Last modified on	2017 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028525