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Study on Improvement of Intestinal Environment and Defecation by Intake of lactic acid bacillus A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study

Study on Improvement of Intestinal Environment and Defecation by Intake of lactic acid bacillus A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study - Study on Improvement of Intestinal Environment and Defecation by Intake of lactic acid bacillus A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052725
Enrollment
60
Registered
2023-11-07
Start date
2023-11-07
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

Healthy 20s female

Interventions

Group A: Dextrin (placebo group) Intake period is 6 weeks. One week before and after intake and 4 weeks after intake One packet (1 g) per day Group B: Dextrin + live lactobacilli (10 billion/g) (te

Sponsors

Ebara Foods industry,Inc. Creative Division Research Institute
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) A healthy female in her 20s (2) Persons who understand the research description and give their consent by their own signature.

Exclusion criteria

Exclusion criteria: (1) Persons who cannot restrict the use of medicines (laxatives, bowel regulators, etc.), health foods, foods for specified health uses, foods with functional claims, health supplements, supplements, etc. that may affect bowel movements, and foods that contain a large amount of lactic acid bacteria after the time consent is obtained (2) Those who are currently receiving medication or outpatient treatment for various illnesses that prevent them from leading a daily life. (3) Persons who are currently under the supervision of a physician for exercise or diet therapy. (4) Persons who are at risk of developing food allergies due to the test foods. (5) Persons with a current or previous history of drug or alcohol dependence. (6) Persons with extremely irregular rhythm of life (eating, sleeping, extremely picky eaters, etc.) (7) Those who are in the hospital for mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea syndrome, etc.), or have a history of mental illness in the past. (8) Those who have participated in other clinical trials (research) within 3 months prior to the date of consent, or have plans to participate in other clinical trials (research) during the study period.

Design outcomes

Primary

MeasureTime frame
Intestinal microflora analysis (conducted twice, before and after ingestion of test product) Stool record (recorded daily during the study period, including one week before and after the intake period)

Secondary

MeasureTime frame
Lifestyle survey (recorded every week during the study period, including one week before and after the intake period) Weight and body composition (conducted twice before and after the intake period)

Countries

Japan

Contacts

Public ContactAtsushi Ohashi

Ebara Foods industry,Inc. Creative Division Research Institute

a.oohashi@ebarafoods.co.jp0465-85-5181

Outcome results

None listed

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