UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025409 |
|---|---|
| Receipt number | 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 17:19:36 |
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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
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
yuki2250@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028525
