UMIN-CTR Clinical Trial

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
Email

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
Email

Sponsor
Institute	Toho University Sakura Medical Center
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007282