UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053709 |
|---|---|
| Receipt number | R000061131 |
| Scientific Title | A Study on the Effect of Food Containing Plant Extract on the intestinal function. -A Randomized, Double-blind, Placebo-controlled, Cross-over Study- |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2024/02/14 14:33:35 |
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Basic information
Public title
A Study on the Effect of Food Containing Plant Extract on the intestinal function.
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Acronym
A Study on the Effect of Food Containing Plant Extract on the intestinal function.
Scientific Title
A Study on the Effect of Food Containing Plant Extract on the intestinal function.
-A Randomized, Double-blind, Placebo-controlled, Cross-over Study-
Scientific Title:Acronym
A Study on the Effect of Food Containing Plant Extract on the intestinal function.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of food containing plant extract on intestinal function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stool frequency
Key secondary outcomes
States of bowel movements
Intestinal environment
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Food containing plant extract, 4 weeks consumption. Wash out. Food not containing plant extract, 4 weeks consumption
Interventions/Control_2
Food not containing plant extract, 4 weeks consumption. Wash out. Food containing plant extract, 4 weeks consumption.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Healthy males and females aged 20 to 64 years-old
(2)Subjects who defecate three to five a week
(3)Subjects who do not habitually consume a large amounts of alcohol
(4)Subjects who regularly eat three meals a day
(5)Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria
Subjects (who)
(1)regularly use intestinal and constipation drugs (including laxatives)
(2)contract or are under treatment for serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease)
(3)have been diagnosed irritable bowel syndrome or inflammatory bowel disease
(4)are under treatment for or have a history of drug addiction and/or alcoholism
(5)can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relieve constipation (including Food for Specified Health Uses or Foods with Function Claims) and/or containing a large amount of sugar alcohol during this study
(6)regularly eat foods containing lactic acid bacteria, bifidobacteria, and/or oligosaccharides to relieve constipation
(7)used antibiotics within the last 2 weeks prior to the screening
(8)have a history and/or a surgical history of digestive disease affecting digestion and absorption
(9)have any food allergies
(10)have excessive alcohol intake more than approximately 20 g / day of pure alcohol equivalent or habit of drinking more than 4 days a week
(11)can't stop drinking from 2 days before each measurement
(12)are shiftworker and/or midnight-shift worker
(13) declare that their menstrual cycle is disturbed
(14)plan to become pregnant after informed consent, pregnant or lactating
(15)have donated over 200 mL of blood and/or blood components within the last 1 month or over 400 mL of blood and/or blood components within the last 3 months prior to the study
(16)plan to participate in other clinical studies during test periods and/or had participated in other clinical studies within the last one month.
(17)are judged unsuitable for the study by the screening
(18)are judged unsuitable for the study by the investigator for other reasons
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Tokushima |
Organization
Maebashi North Hospital
Division name
Director
Zip code
371-0054
Address
692 Shimohosoi-machi,Maebashi-shi,Gumma
TEL
027-235-3333
sagawa@mc-connect.co.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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 | 03 | Month | 31 | 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
| 2024 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | 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 | 02 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061131
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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