UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054049 |
|---|---|
| Receipt number | R000061500 |
| Scientific Title | Investigation of the effects of probiotics on the intestinal microbiota and drug-resistant bacteria of international travelers |
| Date of disclosure of the study information | 2024/04/04 |
| Last modified on | 2024/11/22 09:59:59 |
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Basic information
Public title
Investigation of the effects of probiotics on the intestinal microbiota and drug-resistant bacteria of international travelers
Acronym
Investigation of the effects of probiotics on the intestinal microbiota and drug-resistant bacteria of international travelers
Scientific Title
Investigation of the effects of probiotics on the intestinal microbiota and drug-resistant bacteria of international travelers
Scientific Title:Acronym
Investigation of the effects of probiotics on the intestinal microbiota and drug-resistant bacteria of international travelers
Region
| Japan | Asia(except Japan) |
Condition
Condition
N/A
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of GG lactobacilli and placebo on the intestinal condition of overseas travelers, and to investigate changes in the intestinal environment and stool microflora associated with travel using culture and molecular biological methods. We will compare the results between groups of Japanese who travel abroad by having them consume either the test food (lactobacillus supplement) or the control food (dextrin-substituted food) at a daily dose of about 1 g from 1 month before their travel to 2 months after their return to their home country.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stool characteristics questionnaire: changes in intestinal environment based on Bristol Scale classification
(volume, frequency of defecation, color, hardness, shape, and odor) with and without lactobacillus intake
Key secondary outcomes
Intestinal microbiota analysis(Changes in bacterial occupancy and diversity indices,
Changes in bacterial counts by quantitative PCR method,
Bacterial presence/absence and bacterial count changes by culture method)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
One bottle of LCG lactobacilli per day (about 1 g) for 3 months
Interventions/Control_2
One bottle of dextrin per day (about 1 g) for 3 months
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
| 79 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Have been fully informed of the purpose and content of the study, have the capacity to consent, fully understand the study,and have voluntarily and in writing agreed to participate in the study
2. Healthy Japanese who are between 20 and 79 years of age and who plan to travel abroad during the period of the study
Key exclusion criteria
1. Who currently have a chronic disease of any kind and are receiving drug treatment
2. Those who have participated in other clinical trials or monitoring studies within one month prior to the start of the study,and those who wish to participate in other clinical trials during the period of this study
3. Persons who are taking or will take medicines, quasi-drugs, supplements, health foods, food for specified health uses (Tokuho), or functional foods such as lactic acid bacteria,bifidobacteria, or other intestinal regulators that may affect the results of this study, or are taking or will take them during the study
4. Those who are pregnant, plan to become pregnant during the examination period, or wish to become pregnant
5. Other subjects deemed unsuitable by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Ohira |
Organization
Besuty & Health Research,Inc
Division name
Medical Research Section
Zip code
160-0023
Address
Sankyo NishiShinjuku-Building 4F,4-2-18 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-5354-7388
contact@b-hr.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Kuramochi |
Organization
Besuty & Health Research,Inc
Division name
Medical Research Section
Zip code
160-0023
Address
Sankyo NishiShinjuku-Building 4F,4-2-18 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-5354-7388
Homepage URL
contact@b-hr.jp
Sponsor or person
Institute
Besuty & Health Research,Inc
Institute
Department
Personal name
Funding Source
Organization
Takanashi Milk Products 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
Aibudai Niren Clinic Ethics Review Committee
Address
Chuo Kigyo Bldg., 1-35-10 Sobudai, Zama, Kanagawa, Japan
Tel
09038425192
waki@3smedical.co.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
株式会社ビューティアンドヘルスリサーチ
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 03 | Day |
Last modified on
| 2024 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061500
