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Effects of probiotics on intestinal environment in healthy adults : a double-blind, randomized, placebo-controlled crossover study

Effects of probiotics on intestinal environment in healthy adults : a double-blind, randomized, placebo-controlled crossover study - Effects of probiotics on intestinal environment in healthy adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028811
Enrollment
30
Registered
2017-08-27
Start date
2017-08-28
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 adults

Interventions

Take one pack of test-food-1 a day for 2 weeks - Washout 4 weeks - Take one pack of test-food-2 a day for 2 weeks - Washout 4 weeks - Take one pack of control-food a day for 2 weeks Take one pack of t

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Healthy males and females aged 20 to 60years old. (A half of subjects aim to be men, and the generation of subjects aim to be dispersed.) 2) Subjects who defecate 3 to 5 times in a week. 3) Subjects who show low occupancy of Bifidobacterium in their feces. 4) Subjects who do not routinely consumed fermented foods, health foods which contain dietary fiber, and supplements, during the examination period. 5) Subjects who are explained about the study, show understanding of the study procedures, and show agreement with participating to 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 within 6 month before test start. 3) Subjects who have allergy to test food. 4)Smokers 5)Subjects who are heavy drinkers of alcohol. 6) Subjects whose living together (consort or partner etc.) has plan to participate to the same clinical test. 7) Subjects who plan big change of lifestyle during test period. 8)Subjects with tendency of chronic diarrhea. 9)Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart. 10)Subjects who suspected chronic or serious infectious disease. 11) Females who are pregnant (including the possibility of pregnancy) or are lactating. 12) Subjects who have participated to the other clinical test within 1 month before test start. 13) Subjects who have consumed medicines and foods (yogurt, lactic acid bacteria beverage, oligo-sugar, foods containing dietary fiber etc.) which affect intestinal environment since 2 weeks before the day of advance examination. 14) Subject who cannot refrain from consumption of medicines and foods (yogurt, lactic acid bacteria beverage, oligo-sugar, foods containing dietary fiber etc.) which affect intestinal environment during test period. 15) Subjects who have been determined ineligible by principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Defecation frequency

Secondary

MeasureTime frame
* Analysis of intestinal microbiota * Stool volume, shape, color, smell and feeling after defecation * Constipation assessment scale

Countries

Japan

Contacts

Public ContactMakoto Ichinohe

CPCC Company Limited Plan Sales Department

cpcc-contact@cpcc.co.jp03-5297-3112

Outcome results

None listed

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