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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024130
Receipt No. R000027785
Scientific Title Effect of product containing Euglena gracilis against constipation. A randomized, double-blind, placebo-controlled, crossover-group trial.
Date of disclosure of the study information 2016/09/25
Last modified on 2016/09/22

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Basic information
Public title Effect of product containing Euglena gracilis against constipation. A randomized, double-blind, placebo-controlled, crossover-group trial.
Acronym Effect of product containing Euglena gracilis against constipation.
Scientific Title Effect of product containing Euglena gracilis against constipation. A randomized, double-blind, placebo-controlled, crossover-group trial.
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshitaka Iwama
Organization Nihonbashi Cardiology Clinic
Division name Director
Zip code
Address 13-4 Kodenmacho, Nihonbashi, Chuo-ku, Tokyo
TEL 03-5641-4133
Email yiwama@well-sleep.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mika Komori
Organization KSO Corporation
Division name Sales department
Zip code
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)

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 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

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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
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

Other
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

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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