UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019753 |
|---|---|
| Receipt number | R000022815 |
| Scientific Title | A pilot study on the clinical effect of probiotics "Yasainosenshi" among patients with mild to moderate ulcerative colitis. |
| Date of disclosure of the study information | 2015/11/11 |
| Last modified on | 2017/06/14 21:44:34 |
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Basic information
Public title
A pilot study on the clinical effect of probiotics "Yasainosenshi" among patients with mild to moderate ulcerative colitis.
Acronym
Efficacy of probiotics "Yasainosenshi" among ulcerative colitis
Scientific Title
A pilot study on the clinical effect of probiotics "Yasainosenshi" among patients with mild to moderate ulcerative colitis.
Scientific Title:Acronym
Efficacy of probiotics "Yasainosenshi" among ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of probiotics "Yasainosenshi" for patients with ulcerative colitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement rate of clinical activity (Rachmilewitz's CAI)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Administration of probiotics "Yasainosenshi" for 8 weeks
Interventions/Control_2
After 8 weeks of observation, administration of probiotics "Yasainosenshi" for 8 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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Ulcerative colitis
Mild to moderate disease activity
Constant symptom for 4 weeks
Key exclusion criteria
Cytapheresis therapy
Concomitant antibiotics
Pregnant women
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Andoh |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2217
hqmed2@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeki Bamba |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
Address
Seta-Tsukinowa, Otsu
TEL
077-548-2217
Homepage URL
sb@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
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
| 2015 | Year | 11 | Month | 11 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 13 | 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
| 2015 | Year | 11 | Month | 11 | Day |
Last modified on
| 2017 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022815
