UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004054
Receipt No. R000004859
Scientific Title Effects of probiotics on rheumatoid knee joint required total knee joint arthroplasty
Date of disclosure of the study information 2010/08/23
Last modified on 2013/04/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of probiotics on rheumatoid knee joint required total knee joint arthroplasty
Acronym Effects of probiotics on rheumatoid knee joint required total knee joint arthroplasty
Scientific Title Effects of probiotics on rheumatoid knee joint required total knee joint arthroplasty
Scientific Title:Acronym Effects of probiotics on rheumatoid knee joint required total knee joint arthroplasty
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine a joint fluid, serum cytokine, and arthrosis marker to investigate anti-inflammatory effects of probiotics on RA patients prior to TKA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Concentration of hyaluronic acid (HA) in joint fluid and serum.
Key secondary outcomes DAS28, mHAQ. The concentration of MMP-3 and TNF-alpha in joint fluid. The concentration of MMP-3 in serum. The titer of anti-E-coli antibody

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Probiotics administration group: Start oral administration of 3g a day of probiotics to RA patient 3 months before TKA.
Interventions/Control_2 Non probiotics administration group:
Continue conventional therapy without administration of probiotics.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who are diagnosed with RA according to the ACR criteria
2.Patients with destructive knee joints scheduled for TKA
3.Patients who agreed not to undertake major changes of therapy for RA during the administration period
Key exclusion criteria 1.Patients with allergy to milk or foods which contain lactobacillus
2.Patients with critical complications in heart, kidney, liver, and blood disorder
3.Patients considered to be ineligible by the responsible researcher or assigned researcher
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsushi Ishii
Organization Yokohama City University Medical Center
Division name Center for Rheumatic Diseases
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsushi Ishii
Organization Yokohama City University Medical Center
Division name Center for Rheumatic Diseases
Zip code
Address 4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email ishi69@yokohama-cu.ac.jp

Sponsor
Institute Center for Rheumatic Diseases, Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 横浜市立大学附属市民総合医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 23 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 08 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 17 Day
Last modified on
2013 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004859

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.