UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052253 |
|---|---|
| Receipt number | R000059328 |
| Scientific Title | A dose-ranging study to evaluate the effects of probiotics-containing foods on improving bowel movement -a randomized double-blind placebo-controlled study- |
| Date of disclosure of the study information | 2023/10/30 |
| Last modified on | 2024/09/20 10:44:52 |
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Basic information
Public title
A dose-ranging study to evaluate the effects of probiotics-containing foods on improving bowel movement -a randomized double-blind placebo-controlled study-
Acronym
A dose-ranging study to evaluate the effects of probiotics-containing foods on improving bowel movement -a randomized double-blind placebo-controlled study-
Scientific Title
A dose-ranging study to evaluate the effects of probiotics-containing foods on improving bowel movement -a randomized double-blind placebo-controlled study-
Scientific Title:Acronym
A dose-ranging study to evaluate the effects of probiotics-containing foods on improving bowel movement -a randomized double-blind placebo-controlled study-
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of probiotics-containing foods on improving bowel movement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency
Key secondary outcomes
Defecation time, Stool volume, Bristol stool scale, Stool color, Stool odor, Refreshing feeling after defecation, Feeling of rectal fullness, Straining during defecation, Ease of defecation, Pain during defecation, Good feeling after defecation, Painful urge to defecate, Satisfaction with defecation, Feeling of stool accumulation in the abdomen , Abdominal discomfort, Abdominal distention or bloating, Feeling of heaviness in the abdomen, Feeling of refreshment in the abdomen, Flatus 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
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food 1 for 2 weeks
Interventions/Control_2
Intake of test food 2 for 2 weeks
Interventions/Control_3
Intake of test food 3 for 2 weeks
Interventions/Control_4
Intake of test food 4 for 2 weeks
Interventions/Control_5
Intake of placebo for 2 weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects whose age is 20 years or more and less than 65 years
2) Subjects whose defecation frequency is between 3 and 5 times per week
3) Subjects whose average of Bristol stool scale for a week is 3 or less
4) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1) Subjects who meet the diagnostic criteria for chronic constipation according to chronic constipation medical treatment guidelines 2017
2) Subjects receiving a medical treatment for serious hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders
3) Subjects who have the possibility of developing allergic symptoms by the test food
4) Subjects who take Foods for Specified Health Uses or Foods with Function Claims labeled the intestine function
5) Subjects who take a large amount of foods which would affect the intestine function
6) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
7) Subjects who have collected more than 200 mL of blood within 1 month or more than 400 mL within 3 months prior to the start of the present study (e.g. donated blood)
8) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who are currently taking part in another clinical study
9) Subjects deemed unsuitable by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mamiko |
| Middle name | |
| Last name | Kohno |
Organization
Morishita Jintan Co., Ltd.
Division name
Product Research Group, Research and Development Department, Business Management Headquarters
Zip code
573-0128
Address
2-11-1, Tsudayamate, Hirakata-shi, Osaka
TEL
072-800-1044
m_kohno@jintan.co.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sugino |
Organization
Soiken Inc.
Division name
R&D Division
Zip code
560-0082
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka-shi, Osaka
TEL
0668718888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Morishita Jintan Co., Ltd.
Institute
Department
Personal name
Tomohiro Sugino
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.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 | 10 | Month | 30 | 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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 12 | 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
| 2023 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059328
