UMIN-CTR Clinical Trial

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 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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048416