UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035241 |
|---|---|
| Receipt number | R000040153 |
| Scientific Title | A study for evaluating the viability of lactic acid bacteria in intestinal tract after ingestion of food containing lactic acid bacteria. Second report, an open trial. |
| Date of disclosure of the study information | 2018/12/13 |
| Last modified on | 2019/12/19 10:42:34 |
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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. Second report, 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, second report
Scientific Title
A study for evaluating the viability of lactic acid bacteria in intestinal tract after ingestion of food containing lactic acid bacteria. Second report, 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, second report
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 of viable Lactobacillus brevis in the feces
Key secondary outcomes
Number of Lactobacillus genus in the feces, number of Bifidobacterium genus in the feces, number of total bacteria in the feces, organic acids content in feces, decay product content in feces
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Males and females from 20 to 59 years of age
(2) Subjects giving written informed consent
Key exclusion criteria
(1) Individuals taking antiflatulents and/or laxatives (including purgative drug) and/or health foods in common use, including food for specified health use and food with function claim
(2) Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use
(3) Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use and food with function claim, which influence intestinal regulation during the study period
(4) Individuals presenting known food allergy
(5) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period
(6) Individuals who are under treatment or have a history of drug/alcohol dependence
(7) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics
(8) Individuals who are judged as unsuitable for the study by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keishiro |
| Middle name | |
| Last name | Yoshida |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0275
yoshida_keishirou@lotte.co.jp
Public contact
Name of contact person
| 1st name | Keishiro |
| Middle name | |
| Last name | Yoshida |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0275
Homepage URL
yoshida_keishirou@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Nihonbashi Cardiology Clinic
Address
13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.jp
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
| 2018 | Year | 12 | Month | 13 | 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
10
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
| 2018 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 18 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 21 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 03 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 13 | Day |
Last modified on
| 2019 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040153
