UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000051486
Receipt number	R000058715
Scientific Title	Effects of consumption of the test food on the bowel movement in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Date of disclosure of the study information	2024/12/23
Last modified on	2024/05/27 17:13:21

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Basic information

Public title

Effects of consumption of the test food on the bowel movement in healthy Japanese subjects

Acronym

Effects of consumption of the test food on the bowel movement in healthy Japanese subjects

Scientific Title

Effects of consumption of the test food on the bowel movement in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on the bowel movement in healthy Japanese subjects

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To verify the improving effects on loose stools and the safety of consumption of the test food in healthy Japanese subjects.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Assessment

Primary outcomes

1. The defecation frequency in period 5*

* Period 5: The 4th week after consumption of the test food

Key secondary outcomes

1. The defecation frequency in period 2, 3, and 4*

2. The number of defecation days and amount of defecation in period 2, 3, 4, and 5*

3. Each classification of stool shape, stool color, stool smell, and exhilarating feeling of defecation in period 2, 3, 4, and 5*

4. The subjects whose defecation frequency in period 5* is five times or more and nine times or less

5. The subjects whose defecation frequency which stool shapes are classified as "slightly loose stool" or "muddy stool" are less than 50% of the total defecation frequency in period 5

<Definition>
The number of "slightly loose stool" or "muddy stool" in period 5 / The defecation frequency in period 5 x 100 < 50

6. The subjects whose defecation frequency in period 5* is five times or more and nine times or less, and defecation frequency which stool shapes are classified as "slightly loose stool" or "muddy stool" are less than 50% of the total defecation frequency in period 5

7. The Gastrointestinal Symptom Rating Scale (GSRS) (total score, Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation), the Izumo Scale (total score, each subscale (heartburn, gastralgia, postprandial fullness, constipation, diarrhea)), the rate of water content in stool, and the intestinal flora at four weeks after consumption (4w)

* Period 1: Seven days prior to screening (before consumption: Scr)
Period 2: The 1st week after consumption of the test food
Period 3: The 2nd week after consumption of the test food
Period 4: The 3rd week after consumption of the test food
Period 5: The 4th week after consumption of the test food

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food: Capsule containing killed lactic acid bacteria
Administration: Take one capsule twice daily (morning and night, in total two capsule a day) with water without chewing.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_2

Duration: Four weeks
Test food: Capsule not containing killed lactic acid bacteria
Administration: Take one capsule twice daily (morning and night, in total two capsule a day) with water without chewing.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

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

18 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy subjects

5. Subjects whose defecation frequency for a week prior to Scr is 10 times or more and 20 times or less

6. Subjects whose defecation frequency which stool shape are classified as "slightly loose stool (5)" or "muddy stool (6)" in the Bristol stool scale are 50% or more of the total defecation frequency for a week prior to Scr

Key exclusion criteria

Subjects who
1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2.have a pacemaker or an implantable cardioverter defibrillator
3.have treatment for chronic diseases such as arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, or hypertension
4.usually take "Foods for Specified Health Uses (FOSHU)," or "Foods with Functional Claims (FFC)"
5.are currently taking medicines (including herbal medicines) and supplements
6.are allergic to medicines and/or the test food related products
7.are pregnant, lactating, or planning to become pregnant during this trial
8.suffer from diarrhea
9.have had diarrhea for at least 2 weeks prior to agreeing to participate
10.meet the diagnostic criteria for irritable bowel syndrome (IBS)* or have already been diagnosed with IBS
*Recurrent abdominal pain on average at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria: 1) Related to defecation, 2) Associated with a change in frequency of stool, 3) Associated with a change in form (appearance) of stool
(Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis)
11. have diseases that may substantially affect bowel movement
12.usually take foods containing rich in lactic acid bacteria (LAB), or health foods or medicines fortified with LAB (e.g., yogurt, drink, or supplements)
13.usually take medicines, health foods, FOSHU, or FFC that may affect bowel movement/take foods fortified with ingredients affecting bowel movement (e.g., fermented foods such as natto, kimchi, and pickles, and foods fortified with dietary fiber)
14.take alcohol exceeding 20 g per day
15.have lactose intolerance
16.have been enrolled in other clinical trials within 28 days before agreeing to participate or plan to participate another trial during this trial
17.are judged as ineligible to participate by the physician

Target sample size

Research contact person

Name of lead principal investigator

1st name Tsuyoshi

Middle name

Last name Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

Public contact

Name of contact person

1st name Naoko

Middle name

Last name Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

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

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Sponsor or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Funding Source

Organization

NOF CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Other related organizations

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

IRB Contact (For public release)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

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 (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information

Date of disclosure of the study information

2024 Year 12 Month 23 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

100

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

Completed

Date of protocol fixation

2023 Year 06 Month 14 Day

Date of IRB

2023 Year 06 Month 14 Day

Anticipated trial start date

2023 Year 06 Month 30 Day

Last follow-up date

2023 Year 12 Month 24 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2023 Year 06 Month 30 Day

Last modified on

2024 Year 05 Month 27 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058715