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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042422
Receipt No. 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 2020/11/12

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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
Email soumu@ach2.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Matsui
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
Email food-contact@apoplus.co.jp

Sponsor
Institute APO PLUS STATION CO., LTD.
Institute
Department

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
Email toshiaki.tachikawa@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 Open public recruiting
Date of protocol fixation
2020 Year 11 Month 09 Day
Date of IRB
2020 Year 11 Month 09 Day
Anticipated trial start date
2020 Year 11 Month 12 Day
Last follow-up date
2021 Year 07 Month 15 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
2020 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048416

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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