UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006424 |
|---|---|
| Receipt number | R000007282 |
| Scientific Title | Analysis of intestinal flora by T-RFLP in patients with ulcerative colitis in remission phase and Investigation on the remission-maintaining by probiotic preparation |
| Date of disclosure of the study information | 2011/09/28 |
| Last modified on | 2021/07/19 16:50:31 |
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Basic information
Public title
Analysis of intestinal flora by T-RFLP in patients with ulcerative colitis in remission phase and Investigation on the remission-maintaining by probiotic preparation
Acronym
Analysis of intestinal flora by T-RFLP in patients with ulcerative colitis in remission phase and Investigation on the remission-maintaining by probiotic preparation
Scientific Title
Analysis of intestinal flora by T-RFLP in patients with ulcerative colitis in remission phase and Investigation on the remission-maintaining by probiotic preparation
Scientific Title:Acronym
Analysis of intestinal flora by T-RFLP in patients with ulcerative colitis in remission phase and Investigation on the remission-maintaining by probiotic preparation
Region
| Japan |
Condition
Condition
Patients with ulcerative colitis in remission phase
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy that probiotic (Bio-Three) or placebo in patients with ulcerative colitis in remission is verifying difference-maintaining remission.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Non-relapse rate
Key secondary outcomes
Analysis of intestinal flora and organic acid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bio-Three administration group: 3 tablets t.i.d for 12 months
Interventions/Control_2
Pracebo administration group: 3 tablets t.i.d for 12 months
Interventions/Control_3
Non-administration group: ordinary treatment
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with ulcerative colitis in remission phase when have over 4 weeks.
Key exclusion criteria
1)Patients with serious cardiovascular disease.
2)Patients with serious kidney disease.
3)Patients with hypotension (systolic blood pressure below 80mmHg).
4)Patients with a history of shock caused during extracorporeal circulation treatment.
5)Patients who have complicated severe infectious with sepsis or pneumonia.
6)Patients with hemoglobin(Hb) less than 10mg/dl.
7)Patients who have been in treatment with Leukocytapheresis(LCAP) , Granulocytapheresis(GCAP) or Immunosuppressive drug treatment.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Suzuki |
Organization
Toho University Sakura Medical Center
Division name
Department of Internal Medicine
Zip code
Address
564-1 Shimoshizu Sakura, Chiba 285-8741, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuichi Furukawa |
Organization
Toho University Sakura Medical Center
Division name
Department of Internal Medicine
Zip code
Address
564-1 Shimoshizu Sakura, Chiba 285-8741, Japan
TEL
Homepage URL
Sponsor or person
Institute
Toho University Sakura Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toa Pharmaceutical Co.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
社会保険中央総合病院（東京都）
聖路加国際病院（東京都）
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 28 | Day |
Last modified on
| 2021 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007282
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