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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033804
Receipt No. R000038561
Scientific Title To investigate the effect of probiotics on defecation and metabolism among psy chotic patients
Date of disclosure of the study information 2018/09/01
Last modified on 2018/08/19

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Basic information
Public title To investigate the effect of probiotics on defecation and metabolism among psy
chotic patients
Acronym Probiotics may regulate defecation and metabolism in psychiatry.
Scientific Title To investigate the effect of probiotics on defecation and metabolism among psy
chotic patients
Scientific Title:Acronym Probiotics may regulate defecation and metabolism in psychiatry.
Region
Japan

Condition
Condition psychiatric disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of probiotics on abnormal defecation and metabolic factors retrospectively.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sequential changes regarding defecation and biochemical markers after administration of probiotics.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects were recruited from in-patients who received treatment with probiotics of either BIO-THREE or BIOFERMIN from January 2017 to March 2018 at Kusatsu Hospital in Hiroshima, Japan.
Key exclusion criteria The exclusion criteria was an alternation of medical treatment including probiotics.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MASARU NAKAMURA
Organization Kosekai-Kusatsu Hospital
Division name Department of Internal Medicine
Zip code
Address 10-1, Kusatsu-Umegadai, Nishi Ward, Hiroshima City
TEL 082-277-1001
Email smile1012nakamura@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name MASARU NAKAMURA
Organization Kosekai-Kusatsu Hospital
Division name Department of Internal Medicine
Zip code
Address 10-1, Kusatsu-Umegadai, Nishi Ward, Hiroshima City
TEL 082-277-1001
Homepage URL
Email smile1012nakamura@nifty.com

Sponsor
Institute Kosekai-Kusatsu Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2018 Year 09 Month 01 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 No longer recruiting
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not particular

Management information
Registered date
2018 Year 08 Month 19 Day
Last modified on
2018 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038561

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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