UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

1. Total intestinal bacterial count
*¹ Perform the test at 0 week and at 2 and 4 weeks after the ingestion

Key secondary outcomes

1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)
*¹ Answer CAS-MT at 0 week and at 2 and 4 weeks after the ingestion

2. Stool form scale
*² Answer stool form scale at 0 week and at 2 and 4 weeks after the ingestion

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

4. Analysis of peripheral blood {Diacron-Reactive Oxygen Metabolites (d-ROM), Bone Specific Alkaline Phosphatase (BAP)}
*⁴ Perform the test at 0 week and 4 weeks after the ingestion

5. Stool analysis {Stool IgA, organic acids (succinic acid, lactic acid, formic acid, acetic acid, propionic acid, isobutyric acid, butyric acid, isovaleric acid, valeric acid), ammonia}
*⁵ Analyze at 0 week and at 2 and 4 weeks after the ingestion (Stool IgA: Analyze at 0 week and 4 weeks after the ingestion)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 4 weeks
Test material: ALBEX
Dose: Drink 10 mL twice a day
Administration: To drink ALBEX with a cup of water before breakfast and dinner

Interventions/Control_2

Duration: 4 weeks
Test material: Placebo
Dose: Drink 10 mL twice a day
Administration: To drink Placebo with a cup of water before breakfast and dinner

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

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 bifidobacteria and lactic acid bacteria beverage, bifidobacteria and lactic acid bacteria contains food

5. Subjects who are allergic to medicines or foods related to the test materials of this trial, particularly allergic to soy

6. Subjects who currently take supplements or nutrition enrichments

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 decided as unsuitable for participating in this trial by physician for other reasons

Target sample size

60

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

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

Institute

ORTHOMEDICO, Inc.

Institute

Department

Personal name

Organization

B&S corporation Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Seishin-kai Medical Association Inc, Takara Medical Clinic.

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

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

Date of disclosure of the study information

2016

Year

07

Month

14

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

Completed

Date of protocol fixation

2016

Year

07

Month

11

Day

Date of IRB

Anticipated trial start date

2016

Year

07

Month

15

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

07

Month

13

Day

Last modified on

2017

Year

01

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026691