UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009492 |
|---|---|
| Receipt number | R000011150 |
| Scientific Title | The efficacy and safety of a passive intestinal immune-supplemental milk antibody treatment for rheumatoid arthritis: a multi-center double-blind clinical study |
| Date of disclosure of the study information | 2012/12/06 |
| Last modified on | 2017/06/16 20:30:56 |
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Basic information
Public title
The efficacy and safety of a passive intestinal immune-supplemental milk antibody treatment for rheumatoid arthritis: a multi-center double-blind clinical study
Acronym
Efficacy of milk antibody treatment for rheumatoid arthritis in double-blind clinical study
Scientific Title
The efficacy and safety of a passive intestinal immune-supplemental milk antibody treatment for rheumatoid arthritis: a multi-center double-blind clinical study
Scientific Title:Acronym
Efficacy of milk antibody treatment for rheumatoid arthritis in double-blind clinical study
Region
| Japan |
Condition
Condition
Rheumatoid arthritis (RA)
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical trial will be conducted based on the hypothesis that substances derived from intestinal bacteria, especially endotoxin are one of the pathogenic agents of RA. In the preliminary open clinical study oral administration of whey protein containing milk antibodies to intestinal bacteria and their toxins was effective for the treatment of RA. The present study was designed to ascertain the efficacy of milk antibody treatment for RA in randomised, double-blind clinical study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
ACR response criteria, EULAR response criteria using the 28-joints counts disease activity score using ESR (DAS28-ESR) and newly established evaluation points by modifying ACR criteria.
Key secondary outcomes
Blood levels of TNF, IL-1b, IL-6, IL-17, MIP-1b, CD4, LPB and LPS, immune complex, D-lactic acid, diamine oxidase, etc.
Antibodies to type 2 collagens, LPS and PG-PS. Fecal LPS level and bacterial counts of total bacteria, E. coli, Bacteroides fragilis, Cl. perfringens, Lactobacillus and Bifidobacteria, etc.
HLA typing for HLA-DR.
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
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patients receive milk antibody administration for 12 weeks with the concurrent treatments at a dose of 0mg/man/day (placebo).
Interventions/Control_2
Patients receive milk antibody administration for 12 weeks with the concurrent treatments at a dose of 300mg/man/day.
Interventions/Control_3
Patients receive milk antibody administration for 12 weeks with the concurrent treatments at doses of 600mg/man/day.
Interventions/Control_4
After finishing 12 weeks milk antibody take period, patients who want to have milk antibody will be have another 12 weeks take of 300mg/man/day milk antibody after 12 weeks rest period.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with RA whose disease activity were uncontrolled by authentic medications due to drug resistance or complications and risk factors.
Key exclusion criteria
Patients with milk allergy and those who are treated with biologic agents
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kou Katayama |
Organization
Katayama Orthopedic Rheumatology Clinic
Division name
Department of orthopedic surgery
Zip code
Address
Toyooka 13-4-5-17, Asahikawa, Hokkaido, Japan
TEL
0166-39-1155
kou@kata-rheum.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kou Katayama |
Organization
Katayama Orthopedic Rheumatology Clinic
Division name
Department of orthopedic surgery
Zip code
Address
Toyooka 13-4-5-17, Asahikawa, Hokkaido,
TEL
0166-39-1155
Homepage URL
http://www.kata-rheum.or.jp/dr_info.html
kou@kata-rheum.or.jp
Sponsor or person
Institute
Katayama Orthopedic Rheumatology Clinic
Institute
Department
Personal name
Funding Source
Organization
Asama Chemical Co. Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Abe Clinic Internal Medicine
Uda clinic of Rheumatism Fukuyama
Asama Chemical Co. Ltd
Chondrex Inc.
Seien Drug Compounding
Name of secondary funder(s)
None
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
片山整形外科リウマチ科クリニック(北海道）,Katayama Orthopedic Rheumatology Clinic (Hokkaodo)
安倍内科医院（東京都）, Abe Clinic Internal Medicine (Tokyo)
宇田内科リウマチ科（福山市） Uda clinic of Rheumatism (Fukuyama)
コンドレックスインク（米国）Chondrex Inc (WA,USA)
アサマ化成株式会社（東京） Asama ChemicalCo. Ltd.(Tokyo)
株式会社深井薬局 Seien Drug Compounding (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
RA patients who were resistant to DMARDs therapy were treated with one of the three preparations, Skim milk (prebiotic), Milk antibody preparation containig
600mg of antibody to pathogenic bacteria, and mixed preparation consist of 300mg of milk antibody and skim milk.
The best result was obtaind by use of the mixed preparation as for clinical improvement, correlation between clinical maker
and microflora.
The clinical improvement was seemed to asociated with intestinal barrier,
antagonistic action of bacteroides LPS
against E. coli LPS and reduced serum TNF level.
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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 06 | Day |
Last modified on
| 2017 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011150
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