Functional dyspepsia
Conditions
Interventions
Intake of L.gasseri OLL2716-containing yoghurt(85g) for 12 weeks
Intake of placebo yoghurt (85g) for 12 weeks
Sponsors
Meiji Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese nationals between the ages of 20 and 64 years, with complaints involving the epigastric region, who have not received any treatment. 2. Individuals who have one or more of the 4 symptoms of dyspepsia defined according to the Rome 3 criteria ( postprandial fullness, early satiation, epigastric pain, and epigastric burning) during the preceding 6-month period and have such symptoms regularly during the last 3 months at the time of the screening test. 3. H.pylori-negative individuals, determined as those who meet the following two conditions at the same time: PG2 less than 12 with PG 1/2 ratio not less than 4.5, and serum anti-H.pylori antibody levels (E plate:Eiken) less than 3 U/ml.
Exclusion criteria
Exclusion criteria: 1. Individuals who have consulted medical institutions during the most recent six-month period for diabetes or disorders of the gastrointestinal tract. 2. Individuals who have received medical treatment for dyspepsia symptoms during the 6-month period preceding the study. 3. Individuals who have previously received oral treatments using low-dose aspirin, as well as individuals who have been regularly using non-steroidal anti-inflammatory agents during the 6-month period preceding the study 4. Individuals who are suspected of diabetes, gastrointestinal disorders and severe renal impairment on the basis of blood tests, meidical examination by interview and physical examination at the time of the screening. 5. Individuals who show a marked weight loss during the 3-month period preceding the study 6. Individuals who have experienced a moderate or severe heartburn or reflux symptoms during the 3-month period preceding the study. 7. Individuals who have previously been subjected to an H.pylori eradication therapy. 8. Individuals who have ingested lactic acid bacteria-containing food products 3 times or more per week during the 3-month period preceding the screening tests, excluding individuals who are able to discontinue their intake of the above for 2 weeks or longer preceding the baseline period. 9. Individuals who, for 3 months before the screening tests, regularly use health foods or quasi-drugs with possible influence on gastric symptoms 10. Individuals with milk allergy or food allergies 11. Individuals who, during a one-month period preceding the screening tests, participat in other clinical trials or preliminary studies. 12. Individuals who are pregnant; individuals who plan or want to become pregnant during the study period; individuals who are lactating. 13. Individuals that are considered unsuitable as study participants according to the judgement of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participants' impressions regarding the overall effects on gastric symptoms after 12 weeks of intake of the food products | — |
Countries
Japan
Contacts
Public ContactOhtsu Toshihiro
Meiji Co., Ltd. Food Science Research Laboratories
Outcome results
None listed