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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018002
Receipt No. R000020752
Scientific Title Preventive effect of combination of the Lactobacillus brevis KB290 and beta-carotene on diarrhea-predominant irritable bowel syndrome-like symptoms
Date of disclosure of the study information 2015/06/22
Last modified on 2017/07/11

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Basic information
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
Condition diarrhea-predominant irritable bowel syndrome-like symptoms
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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).

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 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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute imeQ Co.Ltd.
Institute
Department

Funding Source
Organization Kagome 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
Address
Tel
Email

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 医療法人社団慈昂会 白石内科クリニック

Other administrative information
Date of disclosure of the study information
2015 Year 06 Month 22 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
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
Other related information

Management information
Registered date
2015 Year 06 Month 22 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020752

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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