UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024111 |
|---|---|
| Receipt number | R000027757 |
| Scientific Title | A Randomized, Double-Blind, Placebo-Controlled Crossover Study on the Effects of Foods Containing Fermented Plant Extracts on Bowel Movements and Intestinal Flora |
| Date of disclosure of the study information | 2016/09/30 |
| Last modified on | 2016/09/20 16:58:34 |
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Basic information
Public title
A Randomized, Double-Blind, Placebo-Controlled Crossover Study on the Effects of Foods Containing Fermented Plant Extracts on Bowel Movements and Intestinal Flora
Acronym
Effects of Foods Containing Fermented Plant Extracts on Bowel Movements and Intestinal Flora
Scientific Title
A Randomized, Double-Blind, Placebo-Controlled Crossover Study on the Effects of Foods Containing Fermented Plant Extracts on Bowel Movements and Intestinal Flora
Scientific Title:Acronym
Effects of Foods Containing Fermented Plant Extracts on Bowel Movements and Intestinal Flora
Region
| Japan |
Condition
Condition
Male and Female, aged 20-64 years
Mild constipation (2-4 bowel movements per week)
Hard stools, with pain during defecation
Mild constipation that has been present for at least 6 months
Classification by specialty
| Gastroenterology | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of 2 weeks of continuous intake of foods containing fermented plant extracts on bowel movements and intestinal flora
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Number of bowel movements, amount of stool, VAS questionnaire
Key secondary outcomes
Type of intestinal bacterial flora (as determined by 16S rRNA PCR analysis), type of putrefaction products in feces,Blood test, Urine analysis
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
2weeks intake of foods containing fermented plant extracts , 4-weeks washout period,2weeks intake of foods no containing fermented plant extract (placebo), Intake three 580mg soft cupsel for 3 times per day
Interventions/Control_2
2weeks intake of foods no containing fermented plant extract (placebo), 4-weeks washout period, 2weeks intake of foods containing fermented plant extracts
Intake three 580mg soft cupsel for 3 times per day
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Male and Female, aged 20-64 years
(2)Mild constipation (2-4 bowel movements per week)
(3)Hard stools, with pain during defecation
(4)Mild constipation that has been present for at least 6 months
Key exclusion criteria
(1) Individuals with a serious illness, such as diabetes, brain dysfunction, liver disease, kidney disease, heart disease, peripheral vascular disorders, and digestive system disease or those with a history of such illnesses
(2) Individuals currently undergoing treatment for a disease
(3) Individuals who have undergone surgery on the digestive tract
(4) Individuals with food or drug allergies
(5) Individuals routinely using medicinal agents, foods, beverages, or supplements thought to improve constipation
(6) Individuals who drink an excessive amount of alcohol daily or who cannot abstain from alcohol on the day before the study
(7) Individuals engaged in intense sports or dieting
(8) Individuals who are pregnant or who plan to become pregnant or are breastfeeding during the trial period
(9) Individuals who have participated in a clinical trial of an investigational drug or a long-term clinical study of a food or cosmetic product (excluding single-dose studies) within the past 4 weeks and individuals who are currently participating in a clinical study
(10) Individuals judged as being ineligible to participate by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Wakame |
Organization
Hokkaido Pharmaceutical University School of Pharmacy
Division name
Pharmacology
Zip code
Address
7-15-4-1 Maeda,Teine-ku,Sapporo,Hokkaido,006-8590
TEL
011-676-8682
wakame-k@hokuytakudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Wakame |
Organization
Hokkaido Pharmaceutical University School of Pharmacy
Division name
Pharmacology
Zip code
Address
7-15-4-1 Maeda,Teine-ku,Sapporo,Hokkaido,006-8590
TEL
011-676-8682
Homepage URL
wakame-k@hokuytakudai.ac.jp
Sponsor or person
Institute
Hokkaido Pharmaceutical University School of Pharmacy
Institute
Department
Personal name
Funding Source
Organization
Biobank Co,.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Oneness Support Co,.Ltd.
Medical Corporation Kaonnkai Miura Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 09 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 20 | Day |
Last modified on
| 2016 | 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=R000027757
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