UMIN-CTR Clinical Trial

Public title

Preventive effect of combination of the Lactobacillus brevis KB290 and beta-carotene on diarrhea-predominant irritable bowel syndrome-like symptoms

Acronym

Preventive effect of the Lactobacillus brevis KB290 and beta-carotene to IBS-D-like symptoms

Scientific Title

Preventive effect of combination of the Lactobacillus brevis KB290 and beta-carotene on diarrhea-predominant irritable bowel syndrome-like symptoms

Scientific Title:Acronym

Preventive effect of the Lactobacillus brevis KB290 and beta-carotene to IBS-D-like symptoms

Region

Japan

Condition

diarrhea-predominant irritable bowel syndrome-like symptoms

Classification by specialty

Medicine in general

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the preventive effect of Lactobacillus brevis KB290 and beta-carotene on diarrhea-predominant irritable bowel syndrome-like symptoms.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Stool consistency and abdominal pain intensity

Key secondary outcomes

Defecation frequency, urgency, abdominal discomfort, bloating, incomplete evacuation, straining, passage of gas, rugitus and the total score of them (including stool consistency and abdominal pain), work productivity, QOL, inflammatory markers (Interleukin-1beta, Interleukin-12 and Interleukin-10).

Study type

Interventional

Basic design

Parallel

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

Lactobacills brevis KB290 and beta-ene containing capsule (1 capsule/day, for 12 weeks)

Interventions/Control_2

placebo capsule (1 capsule/day, for 12 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

20

years-old

<=

Age-upper limit

49

years-old

>=

Gender

Male and Female

Key inclusion criteria

People who meet all of the following conditions will be required.
1. Who is suffering from diarrhea with abdominal pain and discomfort.
2. Who can ingest the test food during the 12-week study period.
3. Who can visit the Shiraishi internal medicine clinic during the test period.
4. Who can give informed consent by the document based on the individual's intention before the start of the study.

Key exclusion criteria

People who meet any of the following conditions will be excluded.
1. Who is likely to be inflammatory bowel disease, gastrointestinal ulcers, pancreatitis, celiac disease, lactose intolerance, protozoan infection, parasitic infection, other organic gastrointestinal disease or pregnant women.
2. Who uses commercially available drug or a quasi-drugs, for the prevention and treatment of diarrhea with abdominal pain and abdominal discomfort, on a daily basis.
3. Who is currently going to hospital for the treatment of diarrhea with abdominal pain and abdominal discomfort.
4. Who is judged by principal investigator to require medical treatment because of severe diarrhea with abdominal pain and abdominal discomfort.
5. Who has been diagnosed with irritable bowel syndrome.
6. Who has experienced a gastrointestinal surgery, excluding operation for appendicitis.
7. Who is in breast-feeding or pregnancy, or wishes to become pregnant during the study period.
8. Who has been treated for some systemic disease.
9. Who uses non-steroidal anti-inflammatory drugs, steroids or antibiotics on a daily basis.
10. Who is smoker -excluding who have quitted smoking for one year or more.
11. Who has an abnormality in the blood test excluding who is judged by principal investigator as in range of physiological variation.
12. Who had participated in a clinical trial within 90 days before a screening test.
13. Who is irresponsible-mental illness, dementia etc.
14. Who might suffer allergic reaction to the test food -soy, gelatin, egg, milk, wheat, peanut, buckwheat, shrimp, crab, orange, apple or peach.
15. Who is judged as ineligible by principal investigators or researchers.

Target sample size

44

Name of lead principal investigator

1st name
Middle name
Last name	Koichi Aizawa

Organization

Kagome Co.,Ltd.

Division name

Research & Development Division

Zip code

Address

17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan

TEL

0287-36-2935

Email

Koichi_Aizawa@kagome.co.jp

Name of contact person

1st name
Middle name
Last name	Satoshi Sakurai

Organization

imeQ.Inc

Division name

CRO Division

Zip code

Address

2-14-6 Nishi-waseda, Sinjyuku-ku, Tokyo, 169-0075, Japan

TEL

03-6205-6222

Homepage URL

Email

s-sakurai@imeq.co.jp

Institute

imeQ Co.Ltd.

Institute

Department

Personal name

Organization

Kagome Co.,Ltd.

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

医療法人社団慈昂会　白石内科クリニック

Date of disclosure of the study information

2015

Year

06

Month

22

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

2005

Year

05

Month

25

Day

Date of IRB

Anticipated trial start date

2015

Year

06

Month

22

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

06

Month

22

Day

Last modified on

2017

Year

07

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020752