UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022760
Receipt number R000026221
Scientific Title A randomized double-blind placebo-controlled trial for improving the intestinal environment in human
Date of disclosure of the study information 2017/09/01
Last modified on 2018/11/15 12:24:04

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Basic information

Public title

A randomized double-blind placebo-controlled trial for improving the intestinal environment in human

Acronym

A trial for improving the intestinal environment in human

Scientific Title

A randomized double-blind placebo-controlled trial for improving the intestinal environment in human

Scientific Title:Acronym

A trial for improving the intestinal environment in human

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the improvement of intestinal environment due to ingestion of the test food.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. Enterobacterial flora (Bifidobacterium, Lactobacillales, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium cluster XVIII, Clostridium subcluster XIVa, and others)
*1 Perform the test at 0 week and at 1 and 2 weeks after the ingestion

Key secondary outcomes

1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
*1 Perform the test at 0 week and at 1 and 2 weeks after the ingestion

2. Stool form scale
*2 Perform the test at 0 week and at 1 and 2 weeks after the ingestion

3. Bowel movement diary
*3 Recording about the defecation every day


Base

Study type

Interventional


Study design

Basic design

Parallel

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

Duration: 2 weeks
Test material: "Onaka Kaichou Sengen"
Dose: Take 3 sticks a day
Administration: Once a day during a meal

Interventions/Control_2

Duration: 2 weeks
Test material: Placebo
Dose: Take 3 sticks a day
Administration: Once a day during a meal

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese adults

2. Persons who defecate two to five times per week

Key exclusion criteria

1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Subjects who being treated for at least one of following diseases: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

3. Subjects who currently take medicines (include herbal medicines)

4. Subjects who currently take Food for Specified Health Uses, Foods with Functional Claims, yogurt, and/or lactic fermenting beverage

5. Subjects who are allergic to medicines or foods related to the test food of this trial

6. Subjects who currently take supplements or fortified foods

7. Subjects who are pregnant, lactating, or planning to get pregnant during the trial period

8. Subjects who have enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial

9. Subjects are judged as unsuitable for participating in this trial by physician for other reasons

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo YAMAMOTO

Organization

ORTHOMEDICO, Inc.

Division name

R&D Department

Zip code


Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.

TEL

03-3818-0610

Email

kazu@orthomedico.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoko SUZUKI

Organization

ORTHOMEDICO, Inc.

Division name

R&D Department

Zip code


Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.

TEL

03-3818-0610

Homepage URL


Email

nao@orthomedico.jp


Sponsor or person

Institute

ORTHOMEDICO, Inc.

Institute

Department

Personal name



Funding Source

Organization

Aishitoto Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Seishin-kai Medical Association Inc, Takara Medical 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

医療法人社団 盛心会 タカラクリニック
Seishin-kai Medical Association Inc, Takara Medical Clinic.


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Hoshino T, Yamashita S, Suzuki N, Takara T. Effects of Food Containing Resistant Dextrin and Galactooligosaccharides on the Intestinal Environment in Healthy Japanese Adults. -A Randomized, Double-blind, Placebo-controlled, Parallel-group Trial-. Jpn Pharmacol Ther. 2018; 46(10): 1707-1722

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

Completed

Date of protocol fixation

2016 Year 06 Month 13 Day

Date of IRB


Anticipated trial start date

2016 Year 06 Month 16 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 06 Month 15 Day

Last modified on

2018 Year 11 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026221


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name