UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054030 |
|---|---|
| Receipt number | R000061662 |
| Scientific Title | Exploratory study on changes in the intestinal environment during synbiotics intake. |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/04/01 18:23:57 |
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Basic information
Public title
Exploratory study on changes in the intestinal environment during synbiotics intake.
Acronym
Exploratory study on changes in the intestinal environment during synbiotics intake.
Scientific Title
Exploratory study on changes in the intestinal environment during synbiotics intake.
Scientific Title:Acronym
Exploratory study on changes in the intestinal environment during synbiotics intake.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory study on changes in the intestinal environment during synbiotics intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Faecal micorbiota, Faecal metabolites
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
Intake powdered symbiotic 1 for 2 weeks ,powdered symbiotic 2 for 2 weeks ,and powdered prebiotic for 2 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects of both sexes aged 18 years or older and younger than 65 years.
Key exclusion criteria
1. Subjects who regularly use medicine that affect the gut microbiota, such as intestinal regulators, laxatives, etc
2. Subjects who unable to stop ingestion of foods and supplements containing bifidobacteria, oligosaccharide, etc.
3. Subjects with serious disorders on hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, mental and metabolic system, or related severe past medical histories
4. Subjects with medication allergy, food allergy, or serious history of these
5. Subjects who have milk allergy or lactose intolerance
6. Subjects who are pregnant, under lactation or expecting to be pregnant during this study
7. Subjects who participated in other study within 1 month prior to obtaining informed consent
8. Any candidates considered to be inappropriate for this study by the principal investigator based on their background etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Tanaka |
Organization
MORINAGA MILK INDUSTRY CO.,LTD.
Division name
Innovative Research Institute R&D Division
Zip code
252-8583
Address
1-83,5-Chome, Higashihara, Zama-City, Kanagawa-Pref
TEL
046-252-3067
m_tanaka@morinagamilk.co.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Yoshida |
Organization
MORINAGA MILK INDUSTRY CO.,LTD
Division name
Innovative Research Institute R&D Division
Zip code
252-8583
Address
1-83,5-Chome, Higashihara, Zama-City, Kanagawa-Pref
TEL
046-252-3067
Homepage URL
keisuke-yoshida826@morinagamilk.co.jp
Sponsor or person
Institute
Morinaga Milk Industry Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MORINAGA MILK INDUSTRY CO.,LTD., Cabinet Office
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.com
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
| 2024 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061662
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
