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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024111
Receipt No. 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

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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
Email 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
Email wakame-k@hokuytakudai.ac.jp

Sponsor
Institute Hokkaido Pharmaceutical University School of Pharmacy
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027757

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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