UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000050375
Receipt number R000057351
Scientific Title The effects of test food intake on improving defecation : Placebo-controlled, double-blind, randomized, parallel-group comparison study
Date of disclosure of the study information 2024/04/19
Last modified on 2024/06/18 15:56:57

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Basic information

Public title

The effects of test food intake on improving defecation

Acronym

The effects of test food intake on improving defecation

Scientific Title

The effects of test food intake on improving defecation
: Placebo-controlled, double-blind, randomized, parallel-group comparison study

Scientific Title:Acronym

The effects of test food intake on improving defecation
: Placebo-controlled, double-blind, randomized, parallel-group comparison study

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The effects of test foods A intake on improving defecation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Defecation status(number of defecation, days of defecation, form of feces, amount of feces)
The Japanese Version of the Constipation Assessment Scale (CAS-MT)

Key secondary outcomes



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

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of test food A for 4 weeks

Interventions/Control_2

Ingestion of test food B for 4 weeks

Interventions/Control_3

Ingestion of placebo food for 4 weeks

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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Subjects of men and women aged 20 to 64
(2) Subject feeling constipation
(3) Subjects who can come to the clinic on the designated day and undergo the test
(4) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing

Key exclusion criteria

(1) Subjects with a history of diabetes, liver, kidney, digestive, heart, respiratory diseases, peripheral neuropathy, and other serious illness
(2) Subjects with diseases currently being treated
(3) Subjects who are allergic to food and drugs
(4) Subjects who are continuously treated by taking medicines (including OTC and prescription drugs) (excluding external preparation such as compresses and hair growth agents)
(5) Pregnant (including those who may be pregnant) or lactating female subjects
(6) Subjects who cannot stop taking healthy foods with intestinal regulating action (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(7) Subjects with consuming too much alcohol or not abstaining from alcohol from the day before the test to the day of the test
(8) Subjects who are participating in or will participate in other clinical trials at the start of this study.
(9) Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Naoki
Middle name
Last name Miura

Organization

Miura Clinic, Medical Corporation Kanonkai

Division name

Internal medicine

Zip code

530-0044

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka

TEL

06-6135-5200

Email

info@miura-cl.jp


Public contact

Name of contact person

1st name Makoto
Middle name
Last name Terashima

Organization

Oneness Support Co., Ltd.

Division name

Clinical Trial Division

Zip code

530-0044

Address

Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka

TEL

06-4801-8917

Homepage URL


Email

mterashima@oneness-sup.co.jp


Sponsor or person

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name



Funding Source

Organization

Morinaga & 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

Miura Clinic, Medical Corporation Kanonkai IRB

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka

Tel

06-6135-5200

Email

mterashima@miura-cl.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

医療法人花音会みうらクリニック(大阪府) Miura Clinic, Medical Corporation Kanonkai(Osaka)


Other administrative information

Date of disclosure of the study information

2024 Year 04 Month 19 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

2023 Year 02 Month 14 Day

Date of IRB

2023 Year 02 Month 16 Day

Anticipated trial start date

2023 Year 03 Month 10 Day

Last follow-up date

2023 Year 04 Month 30 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 02 Month 17 Day

Last modified on

2024 Year 06 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057351


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name