UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of product containing Euglena gracilis against constipation. A randomized, double-blind, placebo-controlled, crossover-group trial.
Title of the study (Brief title)	Effect of product containing Euglena gracilis against constipation.
Region	Japan

Condition
Condition	people tend to be constipated
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect on bowel movement on people who tend to be constipated throughout the intervention of a product containing Euiglena gracilis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency and days of defecation frequency and amount of defecation will be measured. The changes will be compared with placebo-controlled groups.
Key secondary outcomes	Bristol Stool Form Scale, stool color and smell, feeling after defecation will be measured. The changes will be compared with placebo-controlled groups.

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	YES
Dynamic allocation
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	A glass of powder drink containing Euglena gracilis per day for 2 weeks.
Interventions/Control_2	A glass of placebo powder drink (not containing Euglena gracilis) per day for 2 weeks.
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Who meet the following conditions will be required. Whose defecation frequency is no fewer than 3, nor more than 5, and meal times are three a day usually. (Who gave the informed consents in writing after receiving enough explanation of the purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.)
Key exclusion criteria	Who meet any of the following conditions will be excluded. 1,Who regularly use intestinal drug and laxatives(including strong laxatives). 2,Who use medicine such as antibiotics that affect digestion and absorption. 3,Who can not stop intake the health food to relieve constipation (including Food for Specified Health Uses (FOSHU)) during the screening period. 4,Who can not 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 (FOSHU)) and/or containing a large amount of sugar alcohol during the screening period. 5, Who habitually consume higher amount of alchole (more than 360mL in terms of Japanese Sake per day). 6, Who can not stop intake food containing Euglena gracilis. 7, Who has chronic malady of digestive organ authorities. 8,Who have allergic to food. 9, Who has a medical history of diseases or surgery affecting digestion, absorption and bowel movement (except for appendicectomy). 10,Who have serious diseases requiring an urgent treatment, or who accept severe complication. 11, Who is pregnant or willing to be pregnant or breast-feeding during this study. 12, Who are participated in another clinical trial that intake/apply any of food, drug, and cosmetics, or willing to be that. 13,Who are judged unsuitable for this study by test responsibility doctor.
Target sample size	50

Research contact person
Name of lead principal investigator	Yoshitaka Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Address	13-4 Kodenmacho, Nihonbashi, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	Mika Komori
Organization	KSO Corporation
Division name	Sales department
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	euglena Co.,Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	医療法人財団健康睡眠会　日本橋循環器科クリニック

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 25 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 25 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 22 Day
Last modified on	2016 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027785