UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052110 |
|---|---|
| Receipt number | R000059470 |
| Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to investigate the efficacy in probiotics on intestinal environment in healthy subjects |
| Date of disclosure of the study information | 2023/09/05 |
| Last modified on | 2024/03/06 16:14:03 |
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Basic information
Public title
Randomized, double-blind, placebo-controlled parallel-group comparative study to investigate the efficacy in probiotics on intestinal environment in healthy subjects
Acronym
Clinical study to investigate the efficacy in probiotics on intestinal environment
Scientific Title
Randomized, double-blind, placebo-controlled parallel-group comparative study to investigate the efficacy in probiotics on intestinal environment in healthy subjects
Scientific Title:Acronym
Clinical study to investigate the efficacy in probiotics on intestinal environment
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate comprehensively the effect of probiotics on intestinal environment in healthy subjects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal environment (gut metabolites, gut microbiota)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of probiotic yogurt for 17 days
Interventions/Control_2
Intake of placebo yogurt for 17 days
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects of both sexes aged 18 years or older and younger than 65 years.
Key exclusion criteria
1) Individuals who regularly use medicine that affect the gut microbiota such as Intestinal regulators, laxatives, etc.
2) Individuals who cannot stop ingestion of foods and supplements containing lactic acid bacteria, bifidobacteria, oligosaccharides, etc.
3) Individuals who have disease or serious medical history in liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolism, etc.
4) Individuals who have drug allergy, food allergy or medical history.
5) Individuals who have milk allergy or lactose intolerance.
6) Individuals who are pregnant, under lactation or expecting to be pregnant during this study.
7) Individuals who participated in other clinical trials in the past 1 month or who are going to participate in other trials in this study period.
8) Any candidates considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Furuhata |
Organization
Matsumoto Health Lab
Division name
None
Zip code
390-0811
Address
M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
TEL
0263-39-1139
info@m-health-lab.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Furuhata |
Organization
Matsumoto Health Lab
Division name
None
Zip code
390-0811
Address
M wing 1F, 1-18-1, Chuo, Matsumoto, Nagano, Japan
TEL
0263-39-1139
Homepage URL
info@m-health-lab.jp
Sponsor or person
Institute
Matsumoto Health Lab
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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.com
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
| 2023 | Year | 09 | Month | 05 | 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
39
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
| 2023 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059470
