UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052136 |
|---|---|
| Receipt number | R000059505 |
| Scientific Title | Effects of food containing lactic acid bacteria on gut microbiota -A randomized, double-blind, placebo-controlled, cross-over comparative method- |
| Date of disclosure of the study information | 2023/09/09 |
| Last modified on | 2024/03/08 09:01:24 |
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Basic information
Public title
Effects of food containing lactic acid bacteria on gut microbiota
-A randomized, double-blind, placebo-controlled, cross-over comparative method-
Acronym
Effects of food containing lactic acid bacteria on gut microbiota
Scientific Title
Effects of food containing lactic acid bacteria on gut microbiota
-A randomized, double-blind, placebo-controlled, cross-over comparative method-
Scientific Title:Acronym
Effects of food containing lactic acid bacteria on gut microbiota
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects on gut microbiota and safety of intake food containing lactic acid bacteria for 4 weeks, using placebo as a control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diversity of the gut microbiota
Key secondary outcomes
Analysis of the gut microbiota(next generation-targeted amplicon sequencing), fecal metabolites concentration, fecal water content, quantity of functional substance, and subjective evaluation questionnaire(defecation, quality of life, physical conditions)
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Intake test food for 4 weeks > washout for 4 weeks > Intake placebo for 4 weeks
Interventions/Control_2
Intake placebo for 4 weeks > washout for 4 weeks > Intake test food for 4 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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy men and women aged between 40 and 59
(2) Subjects who have fully comprehended the purpose and content of this study and provide informed consent to participate voluntarily
(3) BMI 25 or more and less than 30 kg/m2
(4) Among subjects who defecation frequency 3 to 5 times a week, select from subjects with high BMI
Key exclusion criteria
Subjects(who)
(1) regularly consume foods that potentially affect the gut microbiota
(2) regularly consume medications or quasi-drug that potentially affect the gut microbiota
(3) undergoing treatment for gastrointestinal diseases that could affect this study or those with a history of gastrointestinal surgery
(4) diagnosed with or having a history of conditions impacting defecation frequency
(5) regularly engage in physical exercise
(6) smoke excessively(more than 21 cigarettes a day)
(7) regularly consume alcohol(more than 40 grams of pure alcohol a day)
(8) are pregnant, breastfeeding, or planning to become pregnant
(9) are judged to be inappropriate as subjects by lifestyle questionnaire
(10) at risk of allergic reactions related to this study
(11) with chronic conditions requiring continuous medication, those undergoing treatment, or those with a history of serious medical conditions requiring medication
(12) are judged as inappropriate for this study based on the results of clinical and physical examination on preliminary examination
(13) with irregular lifestyle patterns due to shift work, night shifts, etc.
(14) undergoing significant lifestyle changes due to moving, traveling abroad, etc.
(15) have participated in another clinical study within the past month or are currently participating in another clinical trial at the start of this study
(16) are judged as inappropriate by investigator
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Seto |
Organization
MEGMILK SNOW BRAND CO., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2 Minamidai, Kawagoe-shi, Saitama
TEL
049-242-8150
sesese-seto@meg-snow.com
Public contact
Name of contact person
| 1st name | Chiharu |
| Middle name | |
| Last name | Goto |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center, Foods Department
Zip code
162-0821
Address
Kagurazaka AK Building, 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
090-1536-4583
Homepage URL
goto.chiharu069@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 09 | 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
| 2023 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059505
