UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039236
Receipt number R000044690
Scientific Title Efficacy evaluation of novel fermented milk drink on healthy adult with a tendency for constipation: A double-blind, randomized, placebo-controlled, parallel group study
Date of disclosure of the study information 2020/01/23
Last modified on 2023/03/16 09:28:51

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Basic information

Public title

Efficacy evaluation of a fermented milk drink

Acronym

Efficacy evaluation of a fermented milk drink

Scientific Title

Efficacy evaluation of novel fermented milk drink on healthy adult with a tendency for constipation: A double-blind, randomized, placebo-controlled, parallel group study

Scientific Title:Acronym

Efficacy evaluation of novel fermented milk drink on healthy adult with a tendency for constipation: A double-blind, randomized, placebo-controlled, parallel group study

Region

Japan


Condition

Condition

Subjects with a tendency for constipation

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Efficacy evaluation of a fermented milk drink on bowel movements, abdominal feelings, gut environments and gut microbiota of healthy adult with tendency for constipation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Bowel movements

Key secondary outcomes

Fecal characteristics
Abdominal feelings
Gut environments
Gut microbiota


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

Fermented milk drink
1 bottle/day for 4 weeks

Interventions/Control_2

Placebo drink
1 bottle/day for 4 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. Subjects with bowel movements between 3 to 5 times a weeks
2. Subjects having an ability to understand study purpose and detail with voluntary written informed consent

Key exclusion criteria

1. Subjects regularly taking laxatives or drugs effective on digestive systems
2. Subjects taking antibiotics or any drugs affect on microbiota
3. Subjects with severe diseases or metabolic diseases regardless under treatment or not
4. Subjects with chronic diseases and taking drug regularly
5. Subject with history of digestive diseases or digestive surgery
6. Subjects regularly taking any functional food products thought to be effective on constipation
7. Subjects unable to stop taking restricted food such as probiotics, prebiotics and any foods thought to be effective on constipation during test period
8. Subjects with drug or alcohol addiction, and history of these
9. Subjects regularly drinking a lot of alcohol
10. Subject unable to stop taking alcohol on the day before the screening test or sampling feces/ urine
11. Subjects with any food allergies
12. Subjects judged as unsuitable for the study participant on the screening test
13. Subjects participating or willing to participate in any other studies of food, drug and cosmetic
14. Pregnant or lactating women, and those who have possibility to become pregnant during the study period
15. Subjects judged as unsuitable for the study participant by principal investigator from other reasons

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Satoru
Middle name
Last name Suzuki

Organization

Shinagawa Season Terrace Health Care Clinic

Division name

Medical examination and treatment management family chief director

Zip code

108-0075

Address

5F Shinagawa season terrace, 1-2-70, Konan, Minato-ku, Tokyo

TEL

03-3452-3382

Email

satoru_suzuki@sempos.or.jp


Public contact

Name of contact person

1st name Eiji
Middle name
Last name Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

7F Omodaka Bldg., 1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL


Email

yoshikawa@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

Yakult Honsha Co.,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

Ethical Committee of Shinagawa Season Terrace Health Care Clinic

Address

5F Shinagawa season terrace, 1-2-70, Konan, Minato-ku, Tokyo

Tel

03-3452-3382

Email

tomohiro_kogo@sempos.or.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

2020 Year 01 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

200

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

delay in manuscript preparation

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

2019 Year 11 Month 21 Day

Date of IRB

2019 Year 11 Month 21 Day

Anticipated trial start date

2020 Year 01 Month 26 Day

Last follow-up date

2020 Year 03 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 01 Month 23 Day

Last modified on

2023 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044690


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name