None
Conditions
Interventions
Oral intake of the study food(12 weeks)
Oral intake of the placebo study food(12 weeks)
Sponsors
CROee.INC
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of gastric emptying | — |
Countries
Japan
Contacts
Public ContactSatomi Nakano
Tokyo Center Clinic Clinical Research Center
Outcome results
None listed