UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004052 |
|---|---|
| Receipt number | R000004860 |
| Scientific Title | Effects of a combination treatment using probiotics and methotrexate (MTX) in patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2010/08/23 |
| Last modified on | 2013/04/02 15:31:06 |
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Basic information
Public title
Effects of a combination treatment using probiotics and methotrexate (MTX) in patients with rheumatoid arthritis
Acronym
Effects of a combination treatment using probiotics and MTX
Scientific Title
Effects of a combination treatment using probiotics and methotrexate (MTX) in patients with rheumatoid arthritis
Scientific Title:Acronym
Effects of a combination treatment using probiotics and MTX
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of a combination treatment using probiotics and MTX to RA disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of DAS28 score before administration, and at 1, 4, 12, 24 weeks after administration
Key secondary outcomes
Improvement of mHAQ and VAS before administration, and at 1, 4, 12, 24 weeks after administration
Investigation of adverse events, clinical examination values, and 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: oral administration of 3g a day of probiotics to RA patient
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.RA patients treated with MTX
3.Patients who agreed not to undertake major changes of therapy for RA during the administration period
4.Patients at the age of 16 or older
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 treated with biologics
4.Patients considered to be ineligible by the responsible researcher or assigned researcher
Target sample size
40
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
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
ishi69@yokohama-cu.ac.jp
Sponsor or person
Institute
Center for Rheumatic Diseases,Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004860
