UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025713 |
|---|---|
| Receipt number | R000029557 |
| Scientific Title | A study for evaluating the viability of lactic acid bacteria in intestinal tract after ingestion of food containing lactic acid bacteria. An open trial. |
| Date of disclosure of the study information | 2017/01/20 |
| Last modified on | 2017/03/30 17:31:36 |
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Basic information
Public title
A study for evaluating the viability of lactic acid bacteria in intestinal tract after ingestion of food containing lactic acid bacteria. An open trial.
Acronym
A study for evaluating the viability of lactic acid bacteria in intestinal tract after intake of food containing lactic acid bacteria.
Scientific Title
A study for evaluating the viability of lactic acid bacteria in intestinal tract after ingestion of food containing lactic acid bacteria. An open trial.
Scientific Title:Acronym
A study for evaluating the viability of lactic acid bacteria in intestinal tract after intake of food containing lactic acid bacteria.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether viable Lactobacillus brevis is detected in the feces after ingestion of food containing lactic acid bacteria for healthy volunteers.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number and rate of subjects that viable Lactobacillus brevis is detected in their feces after ingestion of test food.
Number of viable Lactobacillus brevis in the feces
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Food containing lactic acid bacteria
Interventions/Control_2
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Males and females from 20 to 64 years of age
(2) Subjects who have a daily bowel movement
(3) Subjects giving written informed consent
Key exclusion criteria
(1) Individuals with a loose stool and/or a tendency for constipation
(2) Individuals taking antiflatulents and/or laxatives (including purgative drug) and/or health foods in common use, including food for specified health use
(3) Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use
(4) Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use, which influence intestinal regulation during the study period
(5) Individuals presenting known food allergy
(6) Individuals taking large amounts of alcohol on a daily basis
(7) Individuals who are suffered from a disease which needs treatment urgently or individuals with severe complications
(8) Individuals with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation
(9) Individuals who are under treatment or have a history of irritable bowel syndrome
(10) Individuals who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire
(11) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period
(12) Individuals who are under treatment or have a history of drug/alcohol dependence
(13) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics
(14) Subjects with defecation more than 14 times per week
(15) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Suzuki |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Medical examination and treatment management family chief director
Zip code
Address
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL
03-3452-3381
satoru_suzuki@sempos.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
Address
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Lotte 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
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 20 | 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
| 2016 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2017 | Year | 02 | Month | 18 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 13 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 17 | Day |
Last modified on
| 2017 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029557
