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Changes in gut microbiome and verification of effective dose by test food intake

Changes in gut microbiome and verification of effective dose by test food intake -Randomized double-blind parallel group comparison method- - Changes in gut microbiome and verification of effective dose by test food intake -Randomized double-blind parallel group comparison method-

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040039
Enrollment
100
Registered
2020-04-10
Start date
2020-08-15
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 adult male and female

Interventions

Intake of the low dose of prebiotics material + polymer material dose1, once a day for 2 weeks Intake of the low dose of prebiotics material + polymer material dose2, once a day for 2 weeks Intake of

Sponsors

KSO Corporation
Lead Sponsor
KSO Corporation
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Japanese healthy male and female aged 20-60 years whose defecation frequency is 3-5 times a week (2)Subjects who have low-level Bifidobacterium at the point of screening (3)Subjects who usually take three meals a day (4)Subjects who have received a sufficient explanation of the purpose and contents of the examination, have the ability to consent, have well understood, volunteered to participate, and have signed the informed consent document

Exclusion criteria

Exclusion criteria: (1)Subjects who usually take intestinal drugs and laxatives (2)Subjects who cannot stop the consumption of healthy foods which may have good effect on constipation during the test period (3)Subjects who usually take healthy supplements (4)Subjects who cannot stop the consumption of foods which are containing lactic acid bacteria, bifidobacteria, oligosaccharides, and natto bacteria (probiotics and prebiotics materials ) (5)Subjects who have gastrointestinal disorders or a surgical history and who usually take gastrointestinal drugs (6)Subjects who have been diagnosed irritable bowel syndrome or inflammatory bowel disease (7)Subjects who have liver disease, kidney disease and diabetes mellitus (8)Subjects who have allergic to food (9)Subjects who have pollinosis and take drugs which affects gut microbiome (10)Subjects who are pregnant or breast-feeding, or planning to be pregnant during the test period (11)Subjects who participate in other clinical trials (food, pharmaceuticals and cosmetics), who have participated in other tests within one month of obtaining consent, or who are willing to participate (12)Subjects who are judged as unsuitable for the study by the investigators

Design outcomes

Primary

MeasureTime frame
Composition ratio of gut microbiome

Secondary

MeasureTime frame
-Defecation status -Gastrointestinal condition and appetite -Mood status -Skin condition and sleep quality

Countries

Japan

Contacts

Public ContactKentaro Umeda

Ajinomoto Co., Inc. Institute of Food Sciences and Technologies

kentaro_umeda@ajinomoto.com044-223-4114

Outcome results

None listed

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