UMIN-CTR Clinical Trial

Public title

Verification test of the effect of lactic acid bacterium containing foods intake on functions of the intestines.

Acronym

Verification test of the effect of lactic acid bacterium containing foods intake on functions of the intestines.

Scientific Title

Verification test of the effect of lactic acid bacterium containing foods intake on functions of the intestines.

Scientific Title:Acronym

Verification test of the effect of lactic acid bacterium containing foods intake on functions of the intestines.

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effect of the test food on the regulation of intestinal function in constipation-prone men and women aged 20 to 65 years.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Intestinal flora , Defecation frequency, Fecal amount , Bristol Stool Form Scale

Key secondary outcomes

Vital signs

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

2-week intake of the test food
Wash out
2-week intake of the placebo

Interventions/Control_2

2-week intake of the placebo
Wash out
2-week intake of the test food

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

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Age: 20 years or older, under 65 years of age
2)Gender: Japanese males and females
3)Persons who have had 3 to 5 bowel movements per week

Key exclusion criteria

1)People who regularly drink or drink yogurt containing lactobacilli*Yogurt consumption will not be excluded if habit exists during the study.
2)Patients who cannot limit the use of drugs that may affect bowel movements (e.g., laxatives, intestinal regulators), health foods, specified health foods, functional labeling foods, health .
3)Subjects who were attending the hospital for bowel movements illness at study entry and were taking medications or taking over-the-counter laxatives.
4)Persons who are currently receiving treatment at a medical institution for gastrointestinal diseases that have an effect on the regulation of intestinal function, or those who have undergone.
5)Persons with or with a history of diseases that may significantly affect bowel movements, such as irritable bowel disease and ulcerative colitis.
6)Persons with or with a history of diseases such as diabetes, liver disease, kidney disease, or heart disease.
7)Persons currently undergoing exercise and diet therapy under the supervision of a physician.
8)Persons with diseases requiring constant medication.
9)Persons with a history of serious disease requiring medical treatment.
10)Persons with a history of drug or food allergy.
11)Subjects who are judged inappropriate as subjects based on the responses to the background questionnaire.
12)Subjects with significant deviations from reference ranges in pre-test physical, physical, and laboratory measurements.
13)Pregnant, lactating women, or women who wish to become pregnant during the study.
14)Persons with a current or past history of psychiatric disorders (e.g., depression).
15)Persons who work shift, such as night shift workers.
16)Patients who are receiving or have a history of drug dependence or drug abuse.
17)Individuals who have participated in other human clinical studies or are currently participating in other human clinical studies within the past 3 months.
18)Other subjects who are considered inappropriate as subjects by the investigator.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Ochitani Daisuke

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

Address

Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

81-3-3431-1260

Email

ochitani@huma-c.co.jp

Name of contact person

1st name
Middle name
Last name	Ochitani Daisuke

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

Address

Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

81-3-3431-1260

Homepage URL

Email

ochitani@huma-c.co.jp

Institute

HUMA R&D CORP

Institute

Department

Personal name

Organization

Pickles corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

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

Date of disclosure of the study information

2018

Year

06

Month

01

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

Completed

Date of protocol fixation

2018

Year

04

Month

13

Day

Date of IRB

Anticipated trial start date

2018

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

04

Month

27

Day

Last modified on

2018

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036956