UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044025 |
|---|---|
| Receipt number | R000050272 |
| Scientific Title | The effect of lactic acid bacteria-containing foods on the onset of functional gastrointestinal disorders under stress |
| Date of disclosure of the study information | 2021/04/23 |
| Last modified on | 2021/10/25 14:13:45 |
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Basic information
Public title
The effect of lactic acid bacteria-containing foods on the onset of functional gastrointestinal disorders under stress
Acronym
The effect of lactic acid bacteria-containing foods on the onset of functional gastrointestinal disorders under stress
Scientific Title
The effect of lactic acid bacteria-containing foods on the onset of functional gastrointestinal disorders under stress
Scientific Title:Acronym
The effect of lactic acid bacteria-containing foods on the onset of functional gastrointestinal disorders under stress
Region
| Japan |
Condition
Condition
Functional gastrointestinal disorders
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will prospectively observe the symptoms of irritable bowel syndrome under stress and examine the effects of probiotic-containing foods on improving or preventing the onset of irritable bowel syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Izumo scale between lactic acid bacteria group and placebo group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Levilactobacillus namurensis (Ln) ME-686 Lactobacillus-containing foods should be ingested 3 times a day for 2 months from the start of the training.
Interventions/Control_2
Levilactobacillus namurensis (Ln) ME-686-free dairy products should be taken 3 times a day for 2 months from the start of the training.
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Female National Defense Medical College Self-Defense Forces Candidate Nursing Student Third Grade
Key exclusion criteria
1. Persons with mental illness (judged from medical history)
2. Those who are allergic to milk or lactic acid bacteria
3. Persons with a history of surgery due to intestinal disease
4. Those who cannot obtain consent
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Hokari |
Organization
National Defense Medical College
Division name
Internal medicine 2
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa City, Saitama Prefecture
TEL
04-2995-1511
ryota@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Ito |
Organization
National Defense Medical College
Division name
Internal medicine 2
Zip code
359-8513
Address
3-2 Namiki, Tokorozawa City, Saitama Prefecture
TEL
04-2995-1511
Homepage URL
doc32004@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Defense Medical College Ethics Committee
Address
3-2 Namiki, Tokorozawa City, Saitama Prefecture
Tel
04-2995-1511
ins010@ndmc.ac.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
| 2021 | Year | 04 | Month | 23 | 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
47
Results
Analysis in progress.
Results date posted
| 2021 | Year | 10 | Month | 25 | Day |
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
| 2020 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 23 | Day |
Last modified on
| 2021 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050272
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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