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Test of the effect of 1-Kestose on the intestinal environment of Pregnant Women.

A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study of the Efficacy of 1-Kestose on the Intestinal Environment of infants.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031210088
Enrollment
70
Registered
2021-05-13
Start date
2021-05-13
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

Dermatitis and Eczema

Interventions

Once a day, 1-Kestose or maltose (placebo) 1 grams should be dissolved in food such as baby food or water (water, hot water, tea, miso soup, etc.) and taken before meals. Take it every day, although

Sponsors

Ide Yoshihiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Infants diagnosed with atopic dermatitis who are between 1 and 4 years old at the time of consent acquisition. 2) The research participant whose parent or guardian has received sufficient explanation of the research, understands its contents, and can provide written consent.

Exclusion criteria

Exclusion criteria: Those who use topical steroids classified as strongyles (group I) or belly-strength (group II) as described in the "Atopic Dermatitis Clinical Practice Guidelines 2018 2) Those who have taken drugs (antibiotics) that affect the intestinal environment for one month prior to the start of the test food intake or will take them during the test. 3) Those who have a history of or are currently suffering from serious diseases of the heart, liver, kidneys, digestive organs, etc. 4) Those who are allergic to kestose or maltose. 5) Those who are currently participating in a clinical trial of another drug or health food, or who plan to participate in another clinical trial within 4 weeks after the completion of the trial, or after consenting to participate in the trial. 6) Those who are judged inappropriate to participate in the study by the principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Intestinal microbiota and intestinal metabolites.

Secondary

MeasureTime frame
Saliva IgA content, stool IgA content, defecation status, POEM score and SCOR score

Contacts

Public ContactYoshihiro Ide

Nihonkai General Hospital

ideyosi@nihonkai-hos.jp+81-234-26-2001

Outcome results

None listed

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