UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035057 |
|---|---|
| Receipt number | R000039967 |
| Scientific Title | The effect of continuous intake of the study food on the gastirc motility |
| Date of disclosure of the study information | 2019/08/31 |
| Last modified on | 2019/09/24 16:23:13 |
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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
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
nakano_satomi@tc-clinic.jp
Sponsor or person
Institute
CROee.INC
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
Japan Conference of Clinical Research
Address
Ikebukuto
Tel
03-6869-2920
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039967
