UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007593
Receipt No. 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 (Ver. 12)

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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
Last 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
Email csp-ld@csp.or.jp

Public contact
1st 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
Email s.inoue@csp.or.jp

Sponsor
Institute Public Health Research foundation
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008964