UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized, Double-Blind, Placebo-Controlled Crossover Study on the Effects of Foods Containing Fermented Plant Extracts on Bowel Movements and Intestinal Flora
Title of the study (Brief title)	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	Koji Wakame
Organization	Hokkaido Pharmaceutical University School of Pharmacy
Division name	Pharmacology
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	Koji Wakame
Organization	Hokkaido Pharmaceutical University School of Pharmacy
Division name	Pharmacology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 07 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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