UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007593 |
|---|---|
| Receipt number | R000008964 |
| Scientific Title | Efficacy of Bifidobacterium Breve fermented milk in maintaining remission of ulcerative colitis: Randomized placebo-controlled trial |
| Date of disclosure of the study information | 2012/04/02 |
| Last modified on | 2019/05/09 11:57:10 |
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Basic information
Public title
Efficacy of Bifidobacterium Breve fermented milk in maintaining remission of ulcerative colitis: Randomized placebo-controlled trial
Acronym
B-FLORA
Scientific Title
Efficacy of Bifidobacterium Breve fermented milk in maintaining remission of ulcerative colitis: Randomized placebo-controlled trial
Scientific Title:Acronym
B-FLORA
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy of Bifidobacterium breve fermented milk in maintaining remission of ulcerative colitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
time to event
Key secondary outcomes
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
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Bifidobacterium breve fermented milk
Interventions/Control_2
placebo
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patients who became worse in 96 weeks before the day of entering this study with event1),2),3)or4)
1)experienced bloody-stool for over 7days continously in 2 years - 4 weeks before that day
2)started 5ASA therapy, gained their doses or changed to another blands between 2 years - 4 weeks before that day
3)started LCAP,GCAP or adrenocorticoids therapy, gained their doses between 2 years - 12 weeks before that day
4)started immunomodulator,
immunosuppressant or targeted therapy, gained their doses between 2 years - 12 weeks before that day
(2)Patients who were diagnoised as remission in 4 weeks before that day
(3)Patients who are over 20 and under 70 years old
(4)Patients who made consent documents after informed this study properly
Key exclusion criteria
(1)Patients who are diagnoised as proktitis by endoscope in nearly the day of entering this study
(2)experienced bloody-stool in 4 weeks before that day
(3)changed doses of oral 5ASA therapy or changed to another blands in 4 weeks before that day
(4)started rectal 5ASA or adrenocorticoid therapy in 4 weeks before that day
(5)started oral or parenteral adrenocorticoid therapy in 4 weeks before that day
(6)started LCAP or GCAP therapy in 4 weeks before that day
(7)started immunomodulator therapy in 12 weeks before that day
(8)started immunosuppressant therapy in 12 weeks before that day
(9)started targeted therapy in 12 weeks before that day
(10)use antubiotics for over 14 days in 4 weeks before that day
(11)can not stop to take another probiotics during this study
(12)take reguraly the same probiotics as the test sample in 10 days before that day
(13)register another clinical trials
(14)experienced colon excision
(15)experienced hypersensitivities to proviotics
(16)having serious hepatic or kidney disorder
(17)having mental disorder obviously
(18)having malignant tumor or experienced in 5 years before that day
(19)female who are pregnant, possible to be pregnant or want to be
(20)judged to be exclusive by investigators with another reason
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshifumi Hibi |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Inflammatory Bowel Diseases Center
Zip code
Address
5-9-1 Shirokane Minatoku Tokyo
TEL
03-3444-6161
csp-ld@csp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SATOKO INOUE |
Organization
Public Health Research foundation
Division name
Secretariat,Comprehensive Support Project for Clinical Research of Life-Related Disease
Zip code
Address
1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo
TEL
03-5287-2633
Homepage URL
s.inoue@csp.or.jp
Sponsor or person
Institute
Public Health Research foundation
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha 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
慶應義塾大学病院(東京都)
社会保険中央総合病院(東京都)
東邦大学医療センター佐倉病院(千葉県)
北里東病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
関内鈴木クリニック(神奈川県)
松島クリニック(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 02 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007%2Fs10620-018-4946-2
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs10620-018-4946-2
Number of participants that the trial has enrolled
195
Results
https://link.springer.com/article/10.1007%2Fs10620-018-4946-2
Results date posted
| 2019 | Year | 05 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://link.springer.com/article/10.1007%2Fs10620-018-4946-2
Participant flow
https://link.springer.com/article/10.1007%2Fs10620-018-4946-2
Adverse events
https://link.springer.com/article/10.1007%2Fs10620-018-4946-2
Outcome measures
https://link.springer.com/article/10.1007%2Fs10620-018-4946-2
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 11 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 25 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 26 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 28 | Day |
Last modified on
| 2019 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008964
