UMIN-CTR Clinical Trial

Public title

Effects of OMF-01 on bowel movement of healthy volunteers with a tendency for constipation

Acronym

Effects of OMF-01 on bowel movement of healthy volunteers with a tendency for constipation

Scientific Title

Effects of OMF-01 on bowel movement of healthy volunteers with a tendency for constipation

Scientific Title:Acronym

Effects of OMF-01 on bowel movement of healthy volunteers with a tendency for constipation

Region

Japan

Condition

Healthy adult

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify effects of OMF-01 on bowel movement of healthy volunteers with a tendency for constipation

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

bowel movements (frequency, volume, condition) in the ingestion period

Key secondary outcomes

flora, organic acid, putrefactive products, IgA in feces

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake OMF-01 for 2 weeks , washout for 2 weeks , Intake Dextrin powder for 2 weeks

Interventions/Control_2

Intake Dextrin powder for 2 weeks , washout for 2 weeks , Intake OMF-01 for 2 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

Age-lower limit

40

years-old

<=

Age-upper limit

70

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Subjects with male: age 40 to 70, female: after menopause
2)Subjects with a tendency for constipation(2-4 times / week)
3)Healthy Subjects with no-treatment
4)Obtaining informed consent and signed a consent form

Key exclusion criteria

1) Subjects with a serious liver, kidney, heart damege, diabetes, food allergies, digestive disorder, suffering other serious diseases
2) Subjects having medical history or operation history of digestive disorder
3) Subjects cannot keep the lifestyle
4) Subjects cannot regularly have three meals a day
5)Shifts workers or Late-night workers
6) Subjects whose amount of dietary intake or exercise has changed significantly
7) Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
8) Subjects who take any kind of medicine and/or food for specified health uses and/or supplements and/or diet foods
9) Subjects with drug and food allergies
10) Subjects with a hypersensitivity reaction to test food (eczema, nausea, diarrhea, etc.)
11) Subjects cannot ingest the test food as directed
12) Subjects who usually drink more than 500ml of beer in terms of per day
13) Subjects who take dietary fiber, fermented foods, foods containing a lot of lactic acid bacteria or bifidobacteria or oligosacccharide
14) Subjects who smoked more than 20 average daily
15) Subjects cannot wright a life diary everyday
16) Subjects who participate other clinical trials or investigates in this trial
17) Subjects who are judged not applicable to this study by representative investigator or investigator

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Tohru Nishiyama

Organization

Fuefuki Central Hospital

Division name

Assistant Director

Zip code

Address

47-1, Isawachoyokkaichiba, Fuefuki, Yamanashi, Japan

TEL

055-262-2185

Email

fuefukihp@fch.or.jp

Name of contact person

1st name
Middle name
Last name	Natsumi Oka

Organization

QOL RD Co.,Ltd.

Division name

CRO Department Food Division

Zip code

Address

2-14-1,Nihonbashi,Chuo-Ku,Tokyo, Japan

TEL

03-6386-8809

Homepage URL

Email

n-oka@qol-rd.co.jp

Institute

QOL RD Co.,Ltd.

Institute

Department

Personal name

Organization

Otsuka Pharmaceutical Factory, Inc.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

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

笛吹中央病院（山梨県）、みずの内科クリニック（埼玉県）

Date of disclosure of the study information

2016

Year

05

Month

11

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

Terminated

Date of protocol fixation

2016

Year

04

Month

18

Day

Date of IRB

Anticipated trial start date

2016

Year

05

Month

11

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

05

Month

10

Day

Last modified on

2017

Year

02

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025649