UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000031365 |
|---|---|
| Receipt number | R000035799 |
| Scientific Title | Impact of clinical efficacy of probiotics in hemodialysis patients. |
| Date of disclosure of the study information | 2018/02/19 |
| Last modified on | 2024/02/24 14:27:05 |
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Basic information
Public title
Impact of clinical efficacy of probiotics in hemodialysis patients.
Acronym
Impact of clinical efficacy of probiotics in hemodialysis patients.
Scientific Title
Impact of clinical efficacy of probiotics in hemodialysis patients.
Scientific Title:Acronym
Impact of clinical efficacy of probiotics in hemodialysis patients.
Region
| Japan |
Condition
Condition
Chronic renal failure patients receiving hemodialysis
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of probiotics on the ratio of CRP to albumin and intestinal flora in maintenance hemodialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the changes of the ratio of CRP to albumin before and after administration of probiotics products.
Key secondary outcomes
1. Intestinal flora (next generation sequence)
2. ALP isozyme
3. Serum level of ALP
4. The small intestine gas
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 considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Probiotics products administration group:
BIO-THREE(6g/day, 6 tablets) will be administered 3 times after each meal daily for 24 weeks.
Interventions/Control_2
Placebo administration group:
Placebo(6g/day, 6 tablets) will be administered 3 times after each meal daily for 24 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Patients who have received hemodialysis for more than 3 month.
2 Patinets who have received hemodialysis in the medical institutions conducting this examination
Key exclusion criteria
1 Patients who received peritoneal dialysis
2 Patients whose serum CRP levels were 1.0 mg/dl and over within 1 week
3 Patients who took ethical drugs including probiotics within 1 week
4 Patients with an infection or a sign of an infection within 1 week
5 Patients with an inflammatory disease or a sign of an inflammatory disease
6 Patients with a past history of hypersensitivity to BIO-THREE component
7 Patients considered as inadequate human subjects by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Ogawa |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Blood Purification
Zip code
116-8567
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo
TEL
03-3810-1111
ogawa.tetsuya@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Ogawa |
| Middle name | |
| Last name | Tetsuya |
Organization
Tokyo Women's Medical University Medical Center East
Division name
Blood Purification
Zip code
116-8567
Address
2-1-10 Nishiogu, Arakawa-ku, Tokyo
TEL
03-3810-1111
Homepage URL
ogawa.tetsuya@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
-
-
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
東京女子医科大学東医療センター/Tokyo Women's Medical University Medical Center East(東京都/Tokyo)、富岡クリニック/Tomioka Clinic（群馬県/Gunma）、吉川内科医院/Yoshikawa Clinic(東京都/Tokyo)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 19 | 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
80
Results
The ratio of CRP to albumin did not change before and after treatment in both groups. The serum phosphate levels in the Bio-Three group significantly decreased after 6-month treatment, while did not change in the placebo group. In a 16s rRNA gene-based sequencing protocol analysis, the ratio of Firmicutes, Actinomycetales and Neisseriaies significantly changed after 6 month treatment in the only probiotic group.
Results date posted
| 2024 | Year | 02 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 06 | Month | 07 | Day |
Baseline Characteristics
The patients receiving hemodialysis were randomly assigned to the Bio-Three group (n=37) and the placebo group (n=36).
Participant flow
5 patients excluded.The patients receiving hemodialysis were randomly assigned to the Bio-Three group (n=37) and the placebo group (n=36).In both the Bio-Three group and the placebo group, patients orally received 6 tablets 3 times daily.
Adverse events
no adverse events.
Outcome measures
We evaluated the effect of probiotic on the ratio of CRP to albumin as an inflammation biomarker, other serum data and gut microbioma before and 6 month after the start of treatment. The gut microbioma composition was analyzed by a 16s rRNA gene-based sequencing protocol.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2019 | 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
| 2018 | Year | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035799
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