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A double-blind, randomized controlled trial of the effects of continuous intake of 1-kestose on defecation habits in children in kindergarten

A double-blind, randomized controlled trial of the effects of continuous intake of 1-kestose on defecation habits in children in kindergarten - Defecation improvement test with kestose

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044252
Enrollment
30
Registered
2021-06-01
Start date
2021-07-01
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

constipation

Interventions

1-kestose (3g/day,2months) Maltose (3g/day,2months)

Sponsors

Center for Preventive Medical Sciences, Chiba University
Lead Sponsor
Chiba University Hospital Nouvelle Place Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Those who have consented to participate in the trial from their substitute (guardian) 2) Those who defecate less than 4 times a week 3) Those whose age at the time of obtaining consent by their parents is 3 to 6 years old 4) Those who are certified as No. 1 childcare certification

Exclusion criteria

Exclusion criteria: 1) Those who have a chronic illness and plan to start, end or change drug treatment during the trial period, or those who have a history of serious illness 2) Those who are allergic to test foods 3) Those who plan to start or end the intake of probiotics / prebiotics preparations or foods during the trial period.

Design outcomes

Primary

MeasureTime frame
Changes in the number of defecation days per week (according to the questionnaire)

Secondary

MeasureTime frame
Average number of defecation per week (according to a questionnaire) Fecal properties (by Bristol stool property scale / questionnaire) Changes in the intestinal flora in feces Changes in the number of copies of intestinal bacteria in feces Changes in short-chain fatty acids in feces Incidence of adverse events

Countries

Japan

Contacts

Public ContactMayuko Takahashi

B food science Co., Ltd. Research unit, Research & Development center

m-takahashi@bfsci.co.jp0562-55-1629

Outcome results

None listed

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