UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042422 |
|---|---|
| Receipt number | R000048416 |
| Scientific Title | Verification of gastric symptom improvement effect in continuous intake of the lactic acid bacteria |
| Date of disclosure of the study information | 2020/11/12 |
| Last modified on | 2022/06/24 11:48:54 |
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Basic information
Public title
Verification of gastric symptom improvement effect in continuous intake of the lactic acid bacteria
Acronym
Verification of gastric symptom improvement effect in continuous intake of the lactic acid bacteria
Scientific Title
Verification of gastric symptom improvement effect in continuous intake of the lactic acid bacteria
Scientific Title:Acronym
Verification of gastric symptom improvement effect in continuous intake of the lactic acid bacteria
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effect of improving gastric symptoms with continuous intake of the lactic acid bacteria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of subjective symptoms of stomach and chest when ingesting test food (12 weeks)
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (12 weeks)
Interventions/Control_2
Oral intake of the placebo food (12 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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Japanese healthy males and females aged from 20 to 64 years old
2.Subjects who feel postprandial fullness or early satiation in the questionnaire
3.Subjects who have an ability to understand the purpose and contents of this clinical trial and voluntarily applied and agreed to participate in this clinical trial after the explanation of this clinical trial
Key exclusion criteria
1.Subjects undergoing medical institution consultation or treatment for diabetes, digestive disorders eating disorders, and stress-related psychiatric disorders in the last 6 months
2.Subjects who have received drug treatment for dyspepsia symptoms (antacids, secretory inhibitors, prokinetic agents, nonsteroidal anti-inflammatory drugs, aspirin and antidepressants, etc.) in the last 6 months
3.Subjects suspected of being positive for H. pylori or treated for H. pylori eradication
4.Subjects experiencing severe heartburn or acid reflux on screening tests
5.Subjects suspected of having diabetes, dyslipidemia, gastrointestinal disease and severe renal impairment on screening tests
6.Subjects who have been regularly using drugs, quasi-drugs, yogurt, lactic acid bacteria-containing foods, health food nutritional function food, health food, and supplement for the past month or more
7.Subjects who have been using lactic acid foods such as yogurt, lactic acid bacteria beverages, food for specified health use, nutritional functional food, health food, and supplements regularly for the past month or more
8.Subjects with smoking habits
9.Subjects whose normal drinking amount exceeds 1,000 mL (40 g in terms of alcohol) in terms of beer (5%) per day
10.Subjects with food allergies
11.Individuals who are pregnant individuals who plan or want to become pregnant during the study period individuals who are lactating
12.Subjects with bleeding teeth or oral problems (stomatitis, etc.) during saliva test
13.Subjects with large changes in lifestyle
14.Subjects who travel, travel, or travel abroad for more than a week during the study period, or who may or may not
15.Subjects who have participated in other clinical trial in the past one month, who have a plan to participate in other clinical trial during the test period
16.Subjects who are judged as unsuitable for this clinical trial by the investigator for other reasons
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Fuzisawa |
Organization
Medicial Corporation Aiyukai
Division name
Ageo Central Second Hospital
Zip code
362-0051
Address
421-1 Jitougata, Ageo, Saitama, JAPAN
TEL
048-781-1101
soumu@ach2.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yoshimura |
Organization
APO PLUS STATION CO., LTD.
Division name
CRO Department Clinical Operations Division
Zip code
103-0027
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo, JAPAN
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Ageo Central Second Hospital IRB
Address
421-1 Jitougata, Ageo, Saitama, JAPAN
Tel
048-781-1101
sachimi.ichinokawa@amg.or.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
| 2020 | Year | 11 | Month | 12 | 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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 11 | Day |
Last modified on
| 2022 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048416
