Stomach symptoms (non-diseased state)
Conditions
Interventions
Oral ingestion of food containing inanimate lactic acid bacterium LJ88 about 1 billion cells (6 weeks)
Oral ingestion of Placebo food (6 weeks)
Sponsors
Nihonbashi Cardiology Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Men and women aged between 20 and 64 on the date of obtaining consent (2) Those who have a FSSG score of 8 points or more (3) Those who have received a sufficient explanation of the purpose and contents of the research, have the ability to consent, and who have fully understood and voluntarily applied to participate in this research, and consented to participate in this research in writing.
Exclusion criteria
Exclusion criteria: (1) Those who have a history of Helicobacter pylori infection, or those who are positive for H. pylori antibodies (blood anti-H. pylori antibodies) (2) Those who regularly use drugs that affect stomach symptoms (3) Those who are diagnosed with functional dyspepsia according to the ROME IV criteria (specifically, those who have had upper abdominal symptoms that "feel painful" for more than 6 months and have had the above symptoms for the past 3 months) (4) Those who cannot restrict intake of probiotic foods, prebiotic foods, foods containing lactic acid bacteria and bifidobacteria, and other health foods that are effective in improving gastric symptoms during the study period. (5) Those who have current medical conditions such as organic diseases of the stomach (gastric ulcer, gastric cancer, gastritis, gastroesophageal reflux disease, etc.) (6) Those who have experienced food allergies (7) Those who have frequently become aware of not feeling well due to intake of dairy products. (8) Those who have a disease requiring urgent treatment or who have serious complications (9) Those with gastrointestinal diseases that affect digestion and absorption or defecation, or those with a history of surgery (10) Those who are judged to be unsuitable as research subjects based on the blood test performed in the screening test (11) Pregnant, intending to become pregnant during the research period, or breast-feeding (12) Those who are with a history of drug dependence or alcohol dependence or current illness (13) Those who are participating in research that uses other foods or drugs, or that apply cosmetics or drugs, or those who intend to participate (14) Others who are judged by the principal investigator to be inappropriate as research subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency scale for the symptoms of GERD (FSSG) score after 6 weeks ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) GSRS (2) Stomach symptom questionnaire (comprehensive impression score by research subjects) (3) POMS2 shortened version (4) SF-36v2 Japanese version: Acute version (5) Serum gastrin concentration | — |
Countries
Japan
Contacts
Public ContactYasuhiko Komatsu
Snowden Co., Ltd. R&D, Merchandising Div.
Outcome results
None listed