UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056197 |
|---|---|
| Receipt number | R000064211 |
| Scientific Title | Exploratory study on the effect of a nutritional supplement on intestinal microbiota and nutritional status of chronic kidney disease patients. |
| Date of disclosure of the study information | 2024/11/19 |
| Last modified on | 2025/11/25 13:44:05 |
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Basic information
Public title
Study on the effect of a nutritional supplement on intestinal microbiota and nutritional status of chronic kidney disease patients.
Acronym
Study on the effect of a nutritional supplement on intestinal microbiota and nutritional status of chronic kidney disease patients.
Scientific Title
Exploratory study on the effect of a nutritional supplement on intestinal microbiota and nutritional status of chronic kidney disease patients.
Scientific Title:Acronym
Exploratory study on the effect of a nutritional supplement on intestinal microbiota and nutritional status of chronic kidney disease patients.
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a nutritional supplement containing dietary fiber and oligosaccharides on the intestinal microbiota and nutritional status of chronic kidney disease patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stool-related indicators (fecal microbiota, organic acids, putrefactive products, pH), defecation habits (frequency, number of days, and type of shape), body weight, clinical laboratory indicators (hematological and blood biochemical indicators)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Taking orally one pack of nutritional supplement (150 kcal) per day for 6 weeks
Interventions/Control_2
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) Chronic kidney disease patients aged 20 or more undergoing outpatient care.
(2) Patients in the advanced chronic kidney disease (stage >= 3b) or on hemodialysis
Key exclusion criteria
(1) Persons who regularly use antibiotics or active biologic agents
(2) Persons who regularly use health foods or supplements that improve bowel movements (lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber, etc.)
(3) Persons with a history of gastrointestinal resection
(3) Persons with a history of gastrointestinal resection
(4) Persons who have allergic symptoms due to intake of milk or soy-derived ingredients
(5) Persons who experience abdominal symptoms such as diarrhea upon ingestion of dairy products
(6) Persons who are participating in other clinical trials
(7) Persons who are judged to be unsuitable as subjects by the study director due to subject background, lifestyle, etc.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nakao |
Organization
Medical Corporation Association Showakai
Division name
Bousei Nishi-Shinjuku Clinic
Zip code
160-0023
Address
3-12-12, Nishi-Shinjuku,Shinjuku-ku, Tokyo
TEL
03-5304-5655
t-nakao@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Yoshida |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
Health Care & Nutritional Science Institute, R&D Division
Zip code
252-8583
Address
1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref, Japan
TEL
046-252-3057
Homepage URL
kazuma-yoshida693@morinagamilk.co.jp
Sponsor or person
Institute
Bousei Nishi-Shinjuku Clinic
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyu Medical Research Ethics Review Committee
Address
3-12-12-12 Nishi-Shinjuku, Shinjuku-ku, Tokyo
Tel
046-220-1771
ec@mtz.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | 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
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2024 | Year | 11 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064211
