UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058839 |
|---|---|
| Receipt number | R000067282 |
| Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of probiotics on loose stool. |
| Date of disclosure of the study information | 2025/08/26 |
| Last modified on | 2025/08/19 15:26:38 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of probiotics on loose stool.
Acronym
A study of the effects of probiotics on loose stool.
Scientific Title
A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of probiotics on loose stool.
Scientific Title:Acronym
A study of the effects of probiotics on loose stool.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of probiotic ingestion on stool consistency and frequency in healthy adults with loose stool tendency.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Stool consistency
Key secondary outcomes
Stool frequency
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 test foods for 12 weeks
Interventions/Control_2
Intake of placebo foods for 12 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Participants aged 18-64 years at the time of obtaining consent.
2) Participants with loose stool tendency who defecate more than 7 times a week, with more than 50% of stools categorized as 5 or 6 in the Bristol stool scale.
Key exclusion criteria
1) Participants who regularly take medicines that affect the intestinal environment (antibiotics, bowel medicines, laxatives, etc.).
2) Participants who regularly take foods or supplements that contain lactic acid bacteria, bifidobacteria or oligosaccharides, or that affect the intestinal environment.
3) Participants who cannot stop taking health foods, supplements, foods for specified health uses, foods with functional claims, or foods with nutritional function claims which affect the intestinal environment during the study period.
4) Participants receiving treatment for malignant tumors, respiratory, hepatic, renal, cardiac, lung, gastrointestinal, blood, endocrine or metabolic diseases, or those with a serious history of these diseases.
5) Participants with a history of digestive tract surgery (except adenoidectomy, appendicitis, etc.).
6) Participants who are diagnosed with, or are suspected of having, irritable bowel syndrome (IBS), functional diarrhea, or functional abdominal pain by principal investigator.
7) Participants with serious drug or food allergies or a history of such allergies.
8) Participants who are pregnant, lactating, or planning to become pregnant during the study period.
9) Participants who regularly drink more than moderate alcohol consumption (pure alcohol equivalent 20 g/day).
10) Participants who smoke habitually 20 or more cigarettes per day.
11) Participants who are expected to experience major changes in their environment during the study period (relocation, job change, etc.).
12) Participants with irregular lifestyle or irregular eating habits.
13) Participants who are planning overseas travel or long-term business trips during the study period.
14) Participants who have participated in other clinical trials within 3 months prior to the date of consent, or who plan to participate in other clinical trials during the study period.
15) Participants who are judged ineligible to this study by principal investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Nakamura |
Organization
Matsumoto City Hospital
Division name
None
Zip code
390-1401
Address
4417-180 Hata, Matsumoto, Nagano, Japan
TEL
0263-92-3027
hospi@city.matsumoto.lg.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Todoriki |
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
monitor@m-health-lab.jp
Sponsor or person
Institute
Matsumoto City Hospital
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Research Ethics Committee of Matsumoto City Hospital
Address
4417-180 Hata, Matsumoto, Nagano, Japan
Tel
0263-92-3027
hospi@city.matsumoto.lg.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
| 2025 | Year | 08 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 08 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067282
