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Verification of gastric symptom improvement effect in continuous intake of the lactic acid bacteria

Verification of gastric symptom improvement effect in continuous intake of the lactic acid bacteria - Verification of gastric symptom improvement effect in continuous intake of the lactic acid bacteria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042422
Enrollment
180
Registered
2020-11-12
Start date
2021-06-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Oral intake of the test food (12 weeks) Oral intake of the placebo food (12 weeks)

Sponsors

APO PLUS STATION CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Japanese healthy males and females aged from 20 to 64 years old 2.Subjects who feel postprandial fullness or early satiation in the questionnaire 3.Subjects who have an ability to understand the purpose and contents of this clinical trial and voluntarily applied and agreed to participate in this clinical trial after the explanation of this clinical trial

Exclusion criteria

Exclusion criteria: 1.Subjects undergoing medical institution consultation or treatment for diabetes, digestive disorders eating disorders, and stress-related psychiatric disorders in the last 6 months 2.Subjects who have received drug treatment for dyspepsia symptoms (antacids, secretory inhibitors, prokinetic agents, nonsteroidal anti-inflammatory drugs, aspirin and antidepressants, etc.) in the last 6 months 3.Subjects suspected of being positive for H. pylori or treated for H. pylori eradication 4.Subjects experiencing severe heartburn or acid reflux on screening tests 5.Subjects suspected of having diabetes, dyslipidemia, gastrointestinal disease and severe renal impairment on screening tests 6.Subjects who have been regularly using drugs, quasi-drugs, yogurt, lactic acid bacteria-containing foods, health food nutritional function food, health food, and supplement for the past month or more 7.Subjects who have been using lactic acid foods such as yogurt, lactic acid bacteria beverages, food for specified health use, nutritional functional food, health food, and supplements regularly for the past month or more 8.Subjects with smoking habits 9.Subjects whose normal drinking amount exceeds 1,000 mL (40 g in terms of alcohol) in terms of beer (5%) per day 10.Subjects with food allergies 11.Individuals who are pregnant individuals who plan or want to become pregnant during the study period individuals who are lactating 12.Subjects with bleeding teeth or oral problems (stomatitis, etc.) during saliva test 13.Subjects with large changes in lifestyle 14.Subjects who travel, travel, or travel abroad for more than a week during the study period, or who may or may not 15.Subjects who have participated in other clinical trial in the past one month, who have a plan to participate in other clinical trial during the test period 16.Subjects who are judged as unsuitable for this clinical trial by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Severity of subjective symptoms of stomach and chest when ingesting test food (12 weeks)

Countries

Japan

Contacts

Public ContactHiroki Yoshimura

APO PLUS STATION CO., LTD. CRO Department Clinical Operations Division

food-contact@apoplus.co.jp03-6386-8809

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026