UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049791
Receipt number R000056711
Scientific Title Investigation of the effects of intake of the food containing the lactic acid bacteria on gut environment
Date of disclosure of the study information 2023/02/09
Last modified on 2023/06/30 11:03:29

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Basic information

Public title

Investigation of the effects by ingesting the food containing the lactic acid bacteria on gut environment

Acronym

Investigation of the effects of intake of the food containing the lactic acid bacteria on gut environment

Scientific Title

Investigation of the effects of intake of the food containing the lactic acid bacteria on gut environment

Scientific Title:Acronym

Investigation of the effects of intake of the food containing the lactic acid bacteria on gut environment

Region

Japan


Condition

Condition

Healthy male/female adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate some kind of effect on gut environment by ingesting the food containing the lactic acid bacteria for 4 weeks.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Defecation frequency

Key secondary outcomes

1. Gut microbiota
2. Gut metabolites
3. Defecation status (the number of days, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor)
4. Abdominal symptoms (bloating, borborygmus, gas) at times other than defecation
5. Changes in laboratory values, adverse events and side effects


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Consumption of the test food (4 capsules per day) every day for 4 weeks.

Interventions/Control_2

Consumption of the test food (4 capsules per day) every day for 4 weeks.

Interventions/Control_3

Consumption of the test food (4 capsules per day) every day for 4 weeks.

Interventions/Control_4

Consumption of the test food (4 capsules per day) every day for 4 weeks.

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

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1) At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old.
(2) Subjects who have a bowel evacuation for 3 to 5 times in a week
(3) Subjects who can show their understanding of the study procedure and agreement with participating in the study by written informed consent prior to the study.

Key exclusion criteria

(1) Subjects who have a plan or who have taken the food containing lactic acid bacteria within a month before the trial start, which would affect the trial result.
(2) Subjects who are regularly consuming foods for specified health uses, foods with function claims, supplement and/or health foods, which would affect the trial results for more than 3 times a week.
(3) Subjects who have a plan or who have taken medication within a month before the pre-test start, which would affect the trial result.
(4) Subjects who had undergone appendectomy.
(5) Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent.
(6) Subjects who are expected to undergo major changes in their living environment such as home and work during this trial.
(7) Subjects with irregular dietary habits.
(8) Subjects whose roomer is planning to join this trial.
(9) Subjects who take excessive alcohol.
(10) Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(11) Pregnant, possibly pregnant, or lactating women.
(12) Subjects who are allergic to medicines and test foods (related to lactic acid bacteria).
(13) Subjects who are now under other clinical tests with some kind of medicine/food, or participated in those within a month before this trial, or will join those after giving informed consent to participate in this trial.
(14-16) Subjects who donated their blood components, and/or whole blood as below
- all subjects: 200 mL within a month
- males: 400 mL within the last 3 months
- females: 400 mL within the last 4 months to this trial.
(17-18) Subjects whose collected blood volume within the last 12 months would reach to the following criteria after adding the blood collection in this study;
- males: 1,200 mL
- females: 800 mL
(19) Others who have been determined ineligible by the principal/sub investigator.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Shinnosuke
Middle name
Last name Murakami

Organization

Metagen, Inc.

Division name

Headquarters

Zip code

9970052

Address

246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan

TEL

+81-235-64-0330

Email

research@metagen.co.jp


Public contact

Name of contact person

1st name Shinnosuke
Middle name
Last name Murakami

Organization

Metagen, Inc.

Division name

Headquarters

Zip code

9970052

Address

246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan

TEL

+81-235-64-0330

Homepage URL


Email

research@metagen.co.jp


Sponsor or person

Institute

Metagen, Inc.

Institute

Department

Personal name



Funding Source

Organization

ITO EN, LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Daiwa Building, 3-3-10 Nihonbashihongoku-cho, Chuo-ku, Tokyo 103-0021, Japan

Tel

+81-3-6225-9005

Email

IRB@cpcc.co.jp


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



Other administrative information

Date of disclosure of the study information

2023 Year 02 Month 09 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

Completed

Date of protocol fixation

2022 Year 11 Month 24 Day

Date of IRB

2022 Year 11 Month 18 Day

Anticipated trial start date

2023 Year 02 Month 10 Day

Last follow-up date

2023 Year 03 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 12 Month 15 Day

Last modified on

2023 Year 06 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056711