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The beneficial effect of a newly developed functional food (beverage) containing Lactobacillus powder on human gastrointestinal function.

The beneficial effect of a newly developed functional food (beverage) containing Lactobacillus powder on human gastrointestinal function. - The beneficial effect of a beverage containing Lactobacillus powder on human gastrointestinal function.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016777
Enrollment
120
Registered
2015-03-12
Start date
2015-03-12
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

Individuals with a tendency for constipation or loose stool

Interventions

Intervention Test beverage (containing Lactobacillus powder) Duration: 3 weeks Amount: 200 mL/ bottle, 1 bottle daily Control Placebo beverage Duration: 3 weeks Amount: 200 mL/ bottle, 1 bott

Sponsors

Clinical Support Corporation
Lead Sponsor
Calpis Co. Ltd.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Japanese males and females from 20 to 70 years of age. (2) Those with a tendency for constipation (at 4 times or less of defecation per week), and for loose stool (at 10 times or more of defecation per week). (3) Those taking regular meals.

Exclusion criteria

Exclusion criteria: (1) A medical history of severe disorders, or continuous medical treatment. (2) A surgical history of digestive system (except appendicectomy) (3) Watery stool daily (4) Those who are pregnant or have possibility to become pregnant during the study or breast-feeding. (5) Constantly usage of supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) affecting the test results. (6) Those having an extremely irregular diet habit, alternative work schedule, or work on midnight shift. (7) Those who drink alcohol a lot. (8) Withdrawal of whole blood more than 400mL within 12 weeks, or more than 200mL within 4 weeks, or withdrawal of blood components prior to the current study. (9) Those judged as unsuitable for the study by the principal investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Defecation frequency, defecation days, fecal condition

Secondary

MeasureTime frame
Intestinal microflora composition, organic acids, putrefactive products, questionnaire for QOL

Countries

Japan

Contacts

Public ContactIsao Takehara

Clinical Support Corporation PI-Food Service Division

takehara@csc-smo.co.jp011-223-3130

Outcome results

None listed

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