UMIN-CTR Clinical Trial

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

people tend to be constipated

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

KSO Corporation

Institute

Department

Personal name

Organization

euglena Co.,Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人財団健康睡眠会　日本橋循環器科クリニック

Date of disclosure of the study information

2016

Year

09

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

09

Month

22

Day

Last modified on

2016

Year

09

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027785