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Clinical trial on improving children's QOL through the intestinal environment

Clinical trial on improving children's QOL through the intestinal environment - Clinical trial on improving children's QOL through the intestinal environment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043790
Enrollment
40
Registered
2021-03-31
Start date
2021-05-24
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 Children

Interventions

Intake 2 g of kestose daily for 12 weeks Intake 2 g of maltose daily for 12 weeks

Sponsors

School Corporation Ohkagakuen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Persons whose substitute (guardian) have consented to participate in the trial 2.Japanese who are 3 years old or older and less than 7 years old and first or second year of kindergarten at the time of obtaining consent from their guardian

Exclusion criteria

Exclusion criteria: 1.Persons who have a chronic illness and plan to start, end or change drug treatment during the study period, or those who have a history of serious illness 2.Persons who are allergic to test foods 3.Persons who plan to start or end new intake of probiotics / prebiotics or foods during the study period 4.Persons who used antibacterial drugs within 2 months at the start of the test 5.Persons who are judged to be ineligible by the judgment of the principal investigator or the research coordinator

Design outcomes

Primary

MeasureTime frame
KINDL score

Secondary

MeasureTime frame
Average number of bowel movements per week (according to a questionnaire) Fecal properties (by Bristol stool scale / questionnaire) Changes in the intestinal flora in feces Changes in the copy number of intestinal bacteria in feces Changes in short-chain fatty acids in feces

Countries

Japan

Contacts

Public ContactMayuko Takahashi

B food science Co., Ltd. Research Unit Research and Development Center

m-takahashi@bfsci.co.jp0562-55-1734

Outcome results

None listed

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