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Efficacy evaluation of a fermented milk drink

Efficacy evaluation of novel fermented milk drink on healthy adult with a tendency for constipation: A double-blind, randomized, placebo-controlled, parallel group study - Efficacy evaluation of novel fermented milk drink on healthy adult with a tendency for constipation: A double-blind, randomized, placebo-controlled, parallel group study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000039236
Enrollment
200
Registered
2020-01-23
Start date
2020-01-26
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

Subjects with a tendency for constipation

Interventions

Fermented milk drink 1 bottle/day for 4 weeks Placebo drink 1 bottle/day for 4 weeks

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects with bowel movements between 3 to 5 times a weeks 2. Subjects having an ability to understand study purpose and detail with voluntary written informed consent

Exclusion criteria

Exclusion criteria: 1. Subjects regularly taking laxatives or drugs effective on digestive systems 2. Subjects taking antibiotics or any drugs affect on microbiota 3. Subjects with severe diseases or metabolic diseases regardless under treatment or not 4. Subjects with chronic diseases and taking drug regularly 5. Subject with history of digestive diseases or digestive surgery 6. Subjects regularly taking any functional food products thought to be effective on constipation 7. Subjects unable to stop taking restricted food such as probiotics, prebiotics and any foods thought to be effective on constipation during test period 8. Subjects with drug or alcohol addiction, and history of these 9. Subjects regularly drinking a lot of alcohol 10. Subject unable to stop taking alcohol on the day before the screening test or sampling feces/ urine 11. Subjects with any food allergies 12. Subjects judged as unsuitable for the study participant on the screening test 13. Subjects participating or willing to participate in any other studies of food, drug and cosmetic 14. Pregnant or lactating women, and those who have possibility to become pregnant during the study period 15. Subjects judged as unsuitable for the study participant by principal investigator from other reasons

Design outcomes

Primary

MeasureTime frame
Bowel movements

Secondary

MeasureTime frame
Fecal characteristics Abdominal feelings Gut environments Gut microbiota

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

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