UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025409
Receipt No. R000028525
Scientific Title Efficacy of Clostridium butyricum M588 probiotics for the patients of constipation in schizophrenia: 4 weeks, a randomized, double blinded trial
Date of disclosure of the study information 2017/05/19
Last modified on 2017/05/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of Clostridium butyricum M588 probiotics for the patients of constipation in schizophrenia: 4 weeks, a randomized, double blinded trial
Acronym A randomaized trial of Clostridium butyricum M588 probiotics for the patients of constipation in schizophrenia
Scientific Title Efficacy of Clostridium butyricum M588 probiotics for the patients of constipation in schizophrenia: 4 weeks, a randomized, double blinded trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Nakao Iwata
Organization Fujita Health University
Division name School of Medicine Department of Psychiatry
Zip code
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
1st name
Middle name
Last name Yuki Matsui
Organization Fujita Health University
Division name School of Medicine Department of Psychiatry
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 10 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.