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The evaluation test of intestinal environmental change by intake of Bifidobacterium capsules

The evaluation test of intestinal environmental change by intake of Bifidobacterium capsules - The evaluation test of intestinal environmental change by intake of Bifidobacterium capsules

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018924
Enrollment
24
Registered
2015-09-07
Start date
2015-09-10
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 tendency of constipation

Interventions

Test food : Enteric seamless capsules which contain Bifidobacterium longum JBL01, Intake duration : 2 weeks, Intake amount : 0.53 g/day - Washout 4 weeks - Placebo food : Enteric seamless capsules w

Sponsors

CPCC Company Limited
Lead Sponsor
MORISHITA JINTAN Co.,LTD.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Males and females aged 40 to 60 years old. (2)Subjects, 75% of those defecate between 3 to 6 times in a week, 25% of those defecate 7 times and more in a week. (3)Subjects who don't take fermented foods, dietary fibers and supplements regularly. (4) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.

Exclusion criteria

Exclusion criteria: (1)Subjects who didn't undergo abdominal surgical operation within 6 month before test start. (2)Subjects who didn't take antibiotics for 1 month or more within 6 month before test start. (3) Subjects who have allergy to test food. (4) Subjects who plan big change of lifestyle during test period. (5)Subjects with tendency of chronic diarrhea. (6)Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart. (7)Subjects who suspected chronic or acute infectious disease. (8)Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (9) Subjects who participated the other clinical test within 1 month before test start. (10) Others who have been determined ineligible by principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Improving effect of intestinal environment (bowel movement, intestinal microflora, intestinal metabolite) during 2 weeks of consumption.

Secondary

MeasureTime frame
Questionnaire of physical feeling during 2 weeks of consumption.

Countries

Japan

Contacts

Public ContactMakoto Ichinohe

CPCC Company Limited Plan Sales Department

m.i@cpcc.co.jp03-5297-3112

Outcome results

None listed

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