UMIN-CTR Clinical Trial

Basic information
Public title	The effect of continuous intake of the study food on the gastirc motility
Acronym	The effect of continuous intake of the study food on the gastric motility
Scientific Title	The effect of continuous intake of the study food on the gastirc motility
Scientific Title:Acronym	The effect of continuous intake of the study food on the gastric motility
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect of continuous intake of the study food on the gastric motility
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of gastric emptying
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	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral intake of the study food(12 weeks)
Interventions/Control_2	Oral intake of the placebo study 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents. 2) Japanese individuals, between the ages of 20 and 64 years, with complaints involving the mild or moderate-to-severe gastiric symptom, and who have not received any treatment. 3) Subjects who are confirmed the impaied gastric emptying by screening test
Key exclusion criteria	1)Subjects who consulted a medical institution for diabetes or disorders of the gastrointestinal tract in the past six months. 2)Subjects who received the medical treatment for the dyspepsia symptoms in the past six months. 3)Subjects who is treated with low-dose aspirin or regular use of a non steroidal anti-inflammatory agent for more than the past six months. 4)Subjects who have had bothersome symptoms of dyspepsia during the preceeding 6-manth period (or more), with such symptoms occurring regularly during the last 3-manth period. 5)Subjects who are H.pylori-positive or have received H.pylori eradiation therapy. 6)Subjects who had the severe heartburn or reflex feeling of gastric acid during the one month period. 7)Subjects with suspected diabetes, gastrointestinal disease, or severe nephropathy based on the results of screening test. 8)Subjects with remarkably impaired gastric emptying at the time of the screening 9)Subjects whom the investigator judged to be inappropriate due to a remarkable abnormal quality of life. 10)Subjects who have regulary used medical supplies, quasi-drugs, the health food which may influence a gastric symptom for more than the past one month. 11)Subjects who have been ingesting lactic acid bacteria-containing foods such as yogurt, lactic acid bacteria beverage or intestinal regulators every day for more than the past one month 12)Subjects with the smoking habit. 13)Subjects with the food allergy. 14)Subjects with hypersensitivity to a drug including the nutrient preparation. 15)Participants in another clinical trial or monitored survey in the 1-month period before the screening test, or subjects who are going (or hope) to participate in other clinical trials or a monitor study during the study period. 16)Women who are pregnant, possibly pregnant, or planning to become pregnant during the study period, and women who are breastfeeding. 17)Other subjects who is ineligible for this study due to principal investigator's judgment
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Toshihiro Middle name Last name Ohtsu
Organization	Meiji Co. Ltd.
Division name	Applied Microbilology Research Department Food Microbiology Reseach Laboratories R&D Division
Zip code	192-0919
Address	1-29-1 Nanakuni,Hachiouji,Tokyo 192-0919,JAPAN
TEL	042-632-5842
Email	toshihiro.ohtsu@meiji.com

Public contact
Name of contact person	1st name Satomi Middle name Last name Nakano
Organization	Tokyo Center Clinic
Division name	Clinical Research Center
Zip code	103-0028
Address	2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL	07033513779
Homepage URL
Email	nakano_satomi@tc-clinic.jp

Sponsor
Institute	CROee.INC
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	Japan Conference of Clinical Research
Address	Ikebukuto
Tel	03-6869-2920
Email	nakagawa-kengo@3hcts.co.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	東京センタークリニック（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 31 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	28
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	2018 Year 10 Month 25 Day
Date of IRB	2019 Year 10 Month 19 Day
Anticipated trial start date	2019 Year 01 Month 14 Day
Last follow-up date	2019 Year 05 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	2018 Year 11 Month 28 Day
Last modified on	2019 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039967